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The FDA has approved valbenazine (INGREZZA® SPRINKLE) capsules for adults with tardive dyskinesia and chorea associated with Huntington's disease. This new oral granules formulation provides an alternative for those with swallowing difficulties, maintaining the same dosage strengths as the original capsule form. Valbenazine is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor designed to reduce uncontrollable movements by inhibiting dopamine release.
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Ingrezza for Huntington’s:Tivdak for Cervical Cancer:
Tisotumab vedotin-tftv (TIVDAK) has been approved for recurrent or metastatic cervical cancer after chemotherapy failure. This approval was based on results from a Phase 3 trial showing a significant overall survival benefit compared to chemotherapy. The approval highlights a significant advancement in treating this aggressive form of cancer, granted to Pfizer and Genmab A/S.Xolremdi for WHIM:
Mavorixafor (Xolremdi) has been approved for WHIM syndrome in patients 12 years and older to increase circulating neutrophils and lymphocytes. WHIM syndrome is a rare genetic disorder impairing immune function, and mavorixafor significantly improves cell counts and reduces infection risk. Approval was based on positive results from a double-blind trial and granted to X4 Pharmaceuticals.Esprit Stent for CLTI-BTK:
The FDA has approved the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System for chronic limb-threatening ischemia below-the-knee. This is the first approval of its kind in the U.S., offering an alternative to traditional balloon angioplasty. The approval was based on positive outcomes from the LIFE-BTK trial, showing significant disease progression reduction compared to standard care, granted to Abbott Laboratories. -
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- Fasenra Pediatric Asthma Expansion: No details provided for this update.- Beqvez for Hemophilia B: FDA approved gene therapy, Beqvez, for adults with moderate to severe hemophilia B, which enables the production of clotting protein factor IX. This one-time treatment by Pfizer, derived from Spark Therapeutics, aims to replace frequent infusion therapies, demonstrating superior efficacy in a late-stage trial.
- Anktiva for Bladder Cancer: Anktiva received FDA approval for treating BCG-unresponsive non-muscle invasive bladder cancer, enhancing NK and T cell proliferation. Based on a trial with 77 patients, it showed a 62% complete response rate, surpassing international clinical benchmarks, leading to its designation as a breakthrough therapy.
- Pivya for UTI: FDA approved pivmecillinam (Pivya) for treating uncomplicated urinary tract infections caused by specific bacterial strains. This marks the first new antibiotic for such infections in the U.S. in over 20 years, backed by effective outcomes in three clinical trials.
- Tovorafenib for Pediatric Low-Grade Glioma: Tovorafenib was approved for pediatric low-grade glioma patients with specific BRAF alterations, showing a 67% response rate in the FIREFLY-1 trial. It has been designated for accelerated approval due to its potential in treating these brain tumors.
- Entyvio Maintenance for Crohn’s Disease: Vedolizumab (Entyvio) received approval for subcutaneous administration as Crohn’s disease maintenance therapy after initial intravenous induction. Supported by the VISIBLE 2 Study, it proved effective in maintaining clinical remission at 52 weeks.
- Alecensa for NSCLC: Alecensa was approved as an adjuvant treatment post-tumor resection for ALK-positive non-small cell lung cancer. In the ALINA trial, it significantly extended disease-free survival compared to chemotherapy, particularly in early-stage patients.
- SPG601 for Fragile X Syndrome: The FDA cleared SPG601 for a phase 2a trial in Fragile X Syndrome, addressing synaptic function through BK channel activation. This marks an advance for treating the core symptoms of the most common inherited intellectual disability.
- Lumisight for Visualizing Breast Cancer: The FDA approved Lumisight and the Lumicell Direct Visualization System for use during lumpectomy surgeries to detect residual cancer tissues. This system, shown in the INSITE trial, improves surgical outcomes by reducing the need for second operations.
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- The FDA has expanded the approval of benralizumab (Fasenra) to include children aged 6 to 11 with severe eosinophilic asthma, building on its previous approval for patients aged 12 and older. Benralizumab is a monoclonal antibody that targets and reduces eosinophilic inflammation, crucial in the severe asthma pathway. This approval was supported by the Phase 3 TATE study, which confirmed that the drug's effects in younger children were consistent with those seen in older patients.
- The FDA has approved new administration methods for cenobamate (Xcopri), allowing the tablets to be crushed for oral suspension or delivered via nasogastric tube for adults with partial-onset seizures. Cenobamate, initially approved in 2019, works by inhibiting neuronal firing and modulating the GABA ion channel. The approval follows a study confirming that these new methods are bioequivalent to the original oral intake of intact tablets.
- The FDA's advisory committee has recommended adopting minimal residual disease (MRD) as a new endpoint for the accelerated approval of multiple myeloma treatments. This recommendation is based on the EVIDENCE study, which highlighted MRD's ability to detect very low levels of disease, offering a quicker and more sensitive measure of treatment efficacy. If adopted, MRD could allow for faster approvals and potentially better patient outcomes in multiple myeloma.
- Labcorp's Mpox PCR Test Home Collection Kit has received FDA Emergency Use Authorization for diagnosing mpox in adults, marking the first at-home collection kit for this purpose. The kit uses PCR technology to detect the virus from lesion swabs collected by patients at home. This development comes in response to rising mpox cases and aims to improve accessible diagnostic options during public health emergencies.
- The FDA has approved the use of dolutegravir/lamivudine (Dovato) for HIV treatment in adolescents, making it the first oral, two-drug, single-tablet regimen for this age group. The combination targets crucial steps in the HIV replication process and aims to simplify lifelong treatment regimens, enhancing adherence. Approval was based on the DANCE study's findings, which demonstrated effective viral suppression in adolescents, consistent with adult data.
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Cilta-cel for Myeloma: The FDA approved ciltacabtagene autoleucel (Carvykti; cilta-cel) for adults with relapsed or refractory multiple myeloma who have tried at least one prior therapy including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. This CAR T-cell therapy, initially approved in 2022, was confirmed effective in the phase 3 CARTITUDE-4 study, showing significant reduction in disease progression or death risk by 59% compared to standard care. Enhertu for HER2-positive Solid Tumors: Fam-trastuzumab deruxtecan-nxki (Enhertu) received FDA approval for treating unresectable or metastatic HER2-positive solid tumors in adults who have had previous systemic treatment and lack satisfactory alternative options. This therapy, a conjugate of an anti-HER2 antibody and a cytotoxic drug, was first approved in 2019 and targets HER2-expressing cancer cells to potentially minimize damage to normal tissues. Fanapt for Bipolar: Iloperidone (Fanapt) has been approved for the acute treatment of manic or mixed episodes in adults with bipolar I disorder. Previously approved for schizophrenia, iloperidone targets neurotransmitters like dopamine and serotonin. It demonstrated efficacy in a pivotal trial, showing significant improvement on the Young Mania Rating Scale. Zevtera for Multiple Bacterial Infections: Ceftobiprole medocaril sodium (Zevtera) was approved for treating adults with Staphylococcus aureus bloodstream infections, right-sided infective endocarditis, and acute bacterial skin and skin structure infections. Also approved for pediatric community-acquired bacterial pneumonia, ceftobiprole is a broad-spectrum cephalosporin that combats various bacteria including MRSA. TriClip for Tricuspid Regurgitation: The FDA approved the TriClip™ transcatheter edge-to-edge repair system for treating tricuspid regurgitation. This minimally invasive option clips the tricuspid valve leaflets to improve blood flow and prevent the need for surgery. The TRILUMINATE Pivotal trial showed significant improvements in TR severity and quality of life with a good safety profile. Revumenib for Acute Leukemia: The FDA granted priority review to revumenib (SNDX-5613) for treating adult and pediatric patients with relapsed or refractory acute leukemia with KMT2A rearrangements. As a new therapeutic agent, revumenib inhibits the menin-MLL protein interaction crucial in leukemic transformation. Early trial results show promising remission rates, with a PDUFA action date scheduled for September 26, 2024.
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Winrevair for PAH: Sotatercept-csrk (Winrevair) is FDA-approved for treating adults with pulmonary arterial hypertension (PAH), enhancing exercise capacity, improving WHO functional class, and reducing clinical worsening events. It's the first FDA-approved activin signaling inhibitor for PAH, addressing the imbalance in vascular cell proliferation underlying the condition. The approval is based on the Phase 3 STELLAR trial, demonstrating significant improvements in walk distance and reduced risk of clinical worsening events [1]. Vafseo for CKD: Vadadustat (Vafseo) is approved for managing anemia due to chronic kidney disease (CKD) in adult dialysis patients. As an oral HIF-PH inhibitor, it stimulates endogenous erythropoietin production, offering a novel approach to anemia management. Approval is supported by efficacy and safety data from the INNO2VATE program and post-marketing safety data from Japan [2]. Ultomiris for NMOSD: Ravulizumab-cwvz (Ultomiris) is FDA-approved for treating neuromyelitis optica spectrum disorder (NMOSD) in patients with anti-AQP4 antibodies. It's a terminal complement C5 inhibitor administered once every two months, demonstrating efficacy in preventing relapses. Approval is based on the Phase 3 CHAMPION-NMOSD study, showing significant reductions in relapse risk compared to placebo [3]. Evolut FX+ for TAVR: The Evolut™ FX+ transcatheter aortic valve replacement (TAVR) system is FDA-approved for treating symptomatic severe aortic stenosis. It features enhancements for improved catheter maneuverability without compromising effectiveness. The approval expands treatment options for patients across all risk categories [4]. Vemlidy for Pediatric HBV: Tenofovir alafenamide (Vemlidy) is FDA-approved for treating chronic hepatitis B virus (HBV) infection in pediatric patients aged 6 years and older with compensated liver disease. It's a preferred or first-line treatment option, addressing a significant medical need. Approval is based on the Phase 2 clinical trial 1092, demonstrating efficacy and safety in this patient population [5]. Pemgarda for COVID: Pemgarda, a monoclonal antibody, is FDA-approved for preventive use in immunocompromised individuals aged 12 and older against COVID-19. It prevents virus attachment and has shown promising results in reducing symptomatic COVID-19 cases. Approval is based on emergency use authorization and preliminary data from the CANOPY Phase 3 clinical trial [6]. -
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Nexletol and Nexlizet for LDL Lowering and CV Risk: The FDA approved bempedoic acid (Nexletol) and its combination with ezetimibe (Nexlizet) for reducing cardiovascular risk and treating primary hyperlipidemia. Bempedoic acid inhibits a cholesterol synthesis enzyme, while ezetimibe blocks cholesterol absorption, both lowering LDL-C levels. The approval, for high-risk patients not yet having cardiovascular events, was based on the CLEAR Outcomes trial. Iclusig for ALL: The FDA granted accelerated approval to ponatinib (Iclusig) with chemotherapy for treating previously untreated Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Ponatinib, a tyrosine kinase inhibitor, is the first targeted agent for this leukemia type in combination with chemotherapy, based on the PhALLCON trial results. Further confirmatory data may be required to verify its clinical benefit. Elahere for Ovarian Cancer: Mirvetuximab soravtansine-gynx (Elahere) received FDA approval for treating folate receptor alpha-positive, platinum-resistant ovarian cancer, marking it as the first antibody-drug conjugate in the U.S. for this condition. The treatment targets cancer cells by binding to the folate receptor alpha, delivering a cytotoxic agent. Approval was based on the Phase 3 MIRASOL trial. Duvyzat for DMD: The FDA approved givinostat (Duvyzat) for patients 6 years or older with Duchenne muscular dystrophy (DMD), a rare neuromuscular condition. Givinostat is an HDAC inhibitor that mitigates muscle damage and slows disease progression. Approval was based on the EPIDYS trial results, granted to Italfarmaco S.p.A. Spevigo for Psoriasis: Spesolimab-sbzo (Spevigo) received FDA approval for treating generalized pustular psoriasis (GPP) in adults and pediatric patients, expanding its indication from initial approval for GPP flares. As the first targeted therapy for GPP, it acts as an IL-36 receptor antagonist. The expanded approval was based on the Effisayil 2 trial, showing significant reduction in GPP flares. Tryvio for Hypertension: The FDA approved aprocitentan (Tryvio) in combination with other antihypertensive drugs for adults not adequately controlled on other medications, marking it as the first new oral antihypertensive therapy pathway in nearly 40 years. Based on the PRECISION trial, aprocitentan was shown to be effective in patients with resistant hypertension. Opsynvi for PAH: Macitentan and tadalafil (Opsynvi) was approved by the FDA for adults with pulmonary arterial hypertension (PAH) and WHO functional class II-III, as the first once-daily single-tablet combination therapy for PAH. The approval was based on the A DUE study, demonstrating greater reduction in pulmonary vascular resistance compared to monotherapies. Lenmeldy for Juvenile Metachromatic Leukodystrophy: The FDA approved Lenmeldy (atidarsagene autotemcel) gene therapy for children with metachromatic leukodystrophy (MLD), a rare genetic disease affecting the brain and nervous system. The therapy uses the patient's own genetically modified stem cells to produce the missing enzyme. Approval was based on significant improvements in survival, mobility, and cognitive functions observed in clinical trials and an expanded access program.
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Here is information on the latest US FDA approvals, the week of March 11 – March 15, 2024
Liso-cel for CLL/SLL
- The FDA approved lisocabtagene maraleucel (liso-cel; Breyanzi) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior therapies. It is a CAR T-cell therapy that modifies patient's T cells to target tumor antigens. The approval was based on the TRANSCEND CLL 004 study, showing a 20% complete response rate and a median duration of response not reached by the data cutoff.Tislelizumab for Esophageal SCC
- Tislelizumab-jsgr (Tevimbra) received FDA approval for unresectable or metastatic esophageal squamous cell carcinoma (ESCC) patients after prior systemic chemotherapy. The approval was based on the phase 3 RATIONALE 302 trial, which showed significant improvement in overall survival compared to chemotherapy (8.6 months vs. 6.3 months). This marks a critical advancement for patients with limited treatment options after first-line failures.Resmetirom for NASH
- The FDA approved resmetirom (Rezdiffra) for adults with non-cirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced fibrosis, to be used alongside diet and exercise. This is the first medication approved to directly address liver damage in NASH patients with significant liver scarring, acting as a partial activator of a thyroid hormone receptor to reduce liver fat. The approval, based on a 54-month trial, used a surrogate endpoint at 12 months to demonstrate improvement in liver scarring and inflammation.Maralixibat for Cholestatic Pruritus
- Maralixibat (Livmarli) oral solution was approved for treating cholestatic pruritus in patients aged 5 years and older with progressive familial intrahepatic cholestasis (PFIC). It is an orally administered ileal bile acid transporter inhibitor, showing efficacy in the Phase 3 MARCH clinical trial across various genetic types of PFIC. Additionally, a higher concentration formulation is under consideration to extend its use to younger PFIC patients.Guselkumab for UC
- A supplemental Biologics License Application (sBLA) has been submitted for guselkumab (Tremfya) for treating adults with moderate-to-severely active ulcerative colitis (UC). The submission is based on the QUASAR program results, demonstrating significant clinical remission at Week 44 compared to placebo. Guselkumab, a novel IL-23 inhibitor, has previously been approved for moderate-to-severe plaque psoriasis and active psoriatic arthritis, marking its potential expansion into UC treatment. -
Here is information on the latest US FDA approvals, the week of March 4 – March 8, 2024
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Visit nascentmc.com/podcast for full show notes- **OTC Glucose Monitor**: The FDA has approved the Dexcom Stelo Glucose Biosensor System for over-the-counter sale, a first for a continuous glucose monitor. Designed for people aged 18 and older not using insulin, it helps manage diabetes with oral medications or monitors the impact of diet and exercise on blood sugar levels. Scheduled for release in Summer 2024, the system offers a 15-day sensor wear time and does not alert users to low blood sugar episodes.
- **Semaglutide in CVD Risk**: The FDA has approved semaglutide (Wegovy) for reducing cardiovascular risk in adults with known heart disease who are overweight or obese, specifically targeting the reduction of major adverse cardiovascular events. This approval makes semaglutide the first weight-loss medication also indicated for preventing life-threatening cardiovascular events in patients with established cardiovascular disease and obesity or overweight.
- **Juvederm Additional Indication**: JUVÉDERM® VOLUMA® XC, a hyaluronic acid dermal filler, has received FDA approval for treating moderate to severe temple hollowing in adults over 21, marking it as the first HA filler for this purpose. With effects lasting up to 13 months, clinical studies show significant improvement and patient satisfaction with facial symmetry post-treatment. This approval highlights Allergan Aesthetics' commitment to innovation in aesthetic treatments.
- **Nivolumab in mUC**: The FDA approved nivolumab in combination with cisplatin and gemcitabine for first-line treatment of metastatic urothelial carcinoma, based on significant improvements in survival outcomes from the CHECKMATE-901 trial. This expands nivolumab's indications, which include treatments for melanoma and lung cancer, among others, demonstrating its broad applicability in cancer treatment.
- **Zanubrutinib in FL**: The FDA has granted accelerated approval to zanubrutinib and obinutuzumab for relapsed or refractory follicular lymphoma patients after two or more systemic therapies. This combination targets key pathways in B cell survival, offering a new treatment option for patients. Approval was based on the ROSEWOOD trial, highlighting significant patient outcome improvements.
- **Donanemab and Alzheimer’s**: The FDA has postponed the decision on the approval of Eli Lilly's donanemab for Alzheimer's treatment to convene an advisory meeting for further examination of safety and efficacy data, indicating a significant delay. This reflects the complex nature of Alzheimer's drug approval and Eli Lilly's confidence in donanemab's potential benefits.
- **Tocilizumab Biosimilar**: Tyenne® (tocilizumab-aazg), the first FDA-approved biosimilar to Actemra® for various inflammatory diseases, is now available in both IV and subcutaneous formulations. This approval introduces a new treatment option for patients with conditions like rheumatoid arthritis and juvenile idiopathic arthritis, emphasizing advancements in biosimilar medications.
- **Denosumab Biosimilars**: The FDA approved Jubbonti and Wyost as interchangeable biosimilars to Prolia and Xgeva, respectively, marking a first for biosimilars targeting the RANKL inhibitor used in osteoporosis and cancer-related bone conditions. These approvals offer new treatment options for managing bone health, underlining the importance of biosimilar development in expanding patient care.
- **Clobetasol Propionate Eye Drops**: The FDA's approval of clobetasol propionate 0.05% eye drops for post-operative eye inflammation and pain introduces the first ophthalmic formulation of this corticosteroid and the first new steroid in ophthalmology in over 15 years. Developed using proprietary nanoparticle technology for twice-daily dosing, this approval offers a new option for effective pain and inflammation management post-eye surgery.
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- The FDA has approved amivantamab (Rybrevant) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test. This approval converts the May 2021 accelerated approval of amivantamab to full approval.
- The FDA approved the AGENT Drug-Coated Balloon (DCB) for treating in-stent restenosis in coronary artery disease patients, introducing the first drug-coated coronary balloon in the US. It uses a paclitaxel-coated catheter to deliver medication directly to the vessel wall, offering an alternative to traditional treatments and aiming to reduce recurrence risks. The approval was based on the AGENT IDE trial, demonstrating its effectiveness over uncoated balloon angioplasty in reducing lesion failure, with no significant adverse events reported.
- The FDA approved an oral suspension form of ibrutinib (Imbruvica) for several conditions, including chronic lymphocytic leukemia and chronic graft versus host disease, addressing the needs of patients who have difficulty swallowing pills. This is the first oral suspension formulation of a Bruton's tyrosine kinase inhibitor, originally approved in 2013 for mantle cell lymphoma. The approval, granted to Johnson & Johnson and Pharmacyclics, aims to simplify treatment for patients challenged with pill-swallowing.
- Epcoritamab-bysp (Epkinly) received FDA approval for treating adult patients with relapsed or refractory follicular lymphoma after at least two prior therapies, marking it as the first subcutaneously administered bispecific antibody for this condition. It works by targeting both CD3 on T cells and CD20 on B cells to induce cell death. Based on the EPCORE NHL-1 trial results, this approval extends its use beyond diffuse large B-cell lymphoma, with AbbVie and Genmab sharing commercial responsibilities.
- The FDA granted priority review to the New Drug Application for govorestat (AT-007), a treatment for classic galactosemia, potentially the first of its kind if approved. Govorestat, an aldose reductase inhibitor, aims to reduce harmful galactitol levels, based on phase 3 study results among pediatric patients. Applied Therapeutics announced a PDUFA target action date of August 28, 2024, highlighting the urgent need for treatments in this area.
- Obeticholic acid (Ocaliva) received FDA consideration for an expanded application to treat primary biliary cholangitis, building on its 2016 accelerated approval. It's designed for patients with or without cirrhosis, showing promise in post-marketing studies to confirm its clinical benefits. The review includes data from various studies and real-world evidence, with a PDUFA target date of October 15, 2024, aiming to address the needs of this autoimmune liver disease population.
- The FDA approved Biktarvy for HIV patients with suppressed viral loads who exhibit M184V/I resistance, offering a new treatment option for those with specific resistance mutations. Biktarvy combines three therapies in a single tablet, based on successful 48-week study data. Manufactured by Gilead Sciences, this approval expands treatment possibilities for patients facing resistance challenges.
- The FDA rejected Minerva Neurosciences' New Drug Application for roluperidone as a treatment for schizophrenia's negative symptoms, citing insufficient evidence from a single study and lack of comprehensive data. Despite showing promise in targeting specific brain receptors, the FDA's concerns highlight the need for more extensive research and data to confirm its effectiveness and safety. Minerva plans to engage with the FDA to address these issues.
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Enmetazobactam for cUTI: The FDA approved enmetazobactam (Exblifep) for complicated urinary tract infections (cUTIs) in adults, offering a new weapon against antimicrobial-resistant gram-negative bacteria. It's combined with cefepime, based on successful phase 3 trial results, and is expected to hit the US market soon, addressing the needs of approximately 3.6 million US patients annually. Orchid Pharma receives approval, highlighting the drug's priority review status due to its Qualified Infectious Disease Product designation.
Dupilumab for COPD: Dupilumab (Dupixent) is under priority review by the FDA as a novel biologic therapy for certain adults with uncontrolled chronic obstructive pulmonary disease (COPD), based on promising phase 3 trials. It targets interleukin signaling involved in COPD's inflammatory process, potentially reducing exacerbations and improving lung function over time. If approved, it would be a significant advancement for COPD treatment, offered by Regeneron Pharmaceuticals and Sanofi.Melphalan Flufenamide Withdrawal: The FDA has withdrawn approval for melphalan flufenamide (Pepaxto) for certain multiple myeloma patients due to a lack of confirmed clinical benefit and safety concerns, marking the first application of new procedures for accelerated approval withdrawal. The decision follows the Food and Drug Omnibus Report Act amendments, concluding a process allowing manufacturer Oncopeptides an appeal opportunity.
Teclistamab Biweekly Dosing: Teclistamab-cqyv (Tecvayli) receives FDA approval for biweekly dosing in relapsed or refractory multiple myeloma patients who have maintained a complete response for six months, enhancing treatment flexibility. This approval is based on the phase I/II MajesTEC-1 study, demonstrating maintained responses and safety with the new dosing schedule, highlighting fewer severe infections and no new safety concerns.Linvoseltamab in RRMM: The FDA has granted priority review to the biologics license application for linvoseltamab for treating adult patients with relapsed or refractory multiple myeloma after at least three prior therapies. Targeted for an August 2024 decision, linvoseltamab aims to enhance T-cell activation against cancer cells, supported by promising results from the ongoing LINKER-MM1 trial, offering a new therapeutic option from Regeneron.
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Lifileucel for Melanoma: Lifileucel (Amtagvi) has received accelerated FDA approval for unresectable metastatic melanoma in adults previously treated with specific inhibitors, marking it as the first FDA-approved T cell therapy for solid tumor cancer. The therapy involves collecting and expanding a patient's own T cells from their tumor for reinfusion, demonstrating a 31.5% objective response rate in a global study. A phase 3 trial is in progress to confirm its clinical benefit. Iloprost Injection for Frostbite: The FDA approved Aurlumyn (iloprost) injection, the first-ever treatment for severe frostbite in adults to reduce amputation risk. Iloprost, a vasodilator, showed effectiveness in an open-label trial of 47 adults, offering a significant advancement in managing severe frostbite. MDMA-Assisted Therapy for PTSD: The FDA is considering a new drug application for MDMA-assisted psychotherapy for PTSD, a potential first federal approval of its kind. Supported by two Phase 3 clinical trials showing safety and efficacy, this therapy represents a novel treatment avenue for severe PTSD. NALIRIFOX for Pancreatic Cancer: NALIRIFOX, a combination chemotherapy regimen, has been approved as a first-line treatment for metastatic pancreatic cancer, the first such approval in over a decade. Demonstrating a survival benefit in phase 3 trials, NALIRIFOX offers a new standard for previously untreated patients. Tepotinib for NSCLC: The FDA has fully approved tepotinib (Tepmetko) for NSCLC with MET exon 14 skipping alterations, following accelerated approval in 2021. The approval is based on significant response rates and median overall survival benefits shown in the VISION trial. Omalizumab for Food Allergies: Omalizumab (Xolair) injection is the first FDA-approved medication to reduce the severity of allergic reactions to multiple foods from accidental exposure. Approved for patients aged 1 year and older, it's based on phase 3 trial results showing significant efficacy in preventing reactions to common allergens. Budesonide Oral Suspension for EOE: The FDA approved budesonide oral suspension (Eohilia) as the only oral therapy for eosinophilic esophagitis in patients 11 years and older. This approval offers a specific treatment option for EoE, a chronic disease causing esophageal inflammation and related symptoms. TriClip® for Tricuspid Regurgitation: The FDA approved the TriClip™ TEER system by Abbott for minimally invasive treatment of tricuspid regurgitation, a first-of-its-kind device. Based on the TRILUMINATE trial, the TriClip showed significant improvements in patients' condition and quality of life. ACE2016 for Solid Tumors: The FDA cleared the IND application for ACE2016, an allogeneic gamma delta 2 T cell therapy targeting EGFR-expressing solid tumors. Set to begin in 2024, this Phase 1 trial will evaluate ACE2016's safety, tolerability, and pharmacodynamics. Human Acellular Vessel (HAV) for Vascular Trauma: The FDA granted Priority Review for Humacyte's BLA for the HAV for urgent arterial repair in vascular trauma cases. Supported by clinical trial and real-world evidence, the HAV offers a bioengineered alternative for arterial repair without the need for immune suppression.Free course on ChatGPT4 in medical writing and editing at learnAMAstyle.com
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Eplontersen for ATTR-CM Eplontersen received FDA Fast Track designation for treating transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) in adults, aiming to inhibit TTR protein production.
Nivolumab for NSCLC The FDA accepted supplemental applications for nivolumab in resectable stage 2A to 3B non-small cell lung cancer (NSCLC) based on the CheckMate-77T trial showing improved survival rates.RSV Vaccine for Adults Aged 50 to 59 The FDA prioritizes review of GSK's Arexvy vaccine for RSV in adults aged 50-59 at risk of complications, expanding from its existing approval for those 60 and older.
Spinal Cord Stimulation System The FDA approved Boston Scientific's WaveWriter Spinal Cord Stimulation Systems for chronic low back and leg pain treatment in non-surgery patients, based on the SOLIS trial results.
OK-101 for Neuropathic Corneal Pain The FDA approved an IND application for OK-101, a first for treating neuropathic corneal pain (NCP), an Orphan disease, developed by OKYO Pharma Limited.
Viz ICH Plus for Brain Bleed The FDA cleared Viz ICH Plus, an AI algorithm by Viz.ai for automating the identification and quantification of brain bleeds and structures in NCCT images.
Vepdegestrant for MBC Vepdegestrant received FDA Fast Track designation for treating ER-positive/HER2-negative advanced or metastatic breast cancer in patients previously treated with endocrine therapy.
VerTouch Spinal Puncture Device The FDA cleared VerTouch, a handheld imaging tool by IntuiTap Medical, designed to improve the accuracy of spinal punctures by providing a 2D image of lumbar spinal anatomy. -
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Tricuspid Valve Replacement System for Tricuspid Regurgitation The FDA approved the Evoque tricuspid valve replacement system, a first in the U.S. for a transcatheter tricuspid device, after the TRISCEND II trial showed significant improvements in TR grade and patient symptoms. TR, where the heart's valve does not close properly causing blood backflow, can now be treated with this device, which also received CE Mark approval in Europe and is produced by Edwards Lifesciences. Afami-Cel for Synovial Sarcoma The FDA is prioritizing the review of afamitresgene autoleucel (afami-cel) for advanced synovial sarcoma, based on positive results from the SPEARHEAD-1 trial showing a 39% response rate and increased survival rates. Afami-cel targets MAGE-A4 in synovial sarcoma, a rare soft tissue sarcoma, offering a new treatment option for this aggressive disease. It's manufactured by Adaptimmune Therapeutics with a decision expected by August 4, 2024. Pulsed Field Ablation for Atrial Fibrillation Boston Scientific's FARAPULSE PFA System has been FDA approved for treating intermittent atrial fibrillation, offering a non-thermal, tissue-selective ablation alternative with proven safety and efficacy. The approval was based on the ADVENT study and real-world data, highlighting shorter ablation times and no severe side effects. Boston Scientific plans an immediate U.S. launch. Shorter Turnaround Time for Axi-cel The FDA approved a manufacturing process change for axi-cel (Yescarta), reducing delivery time from 16 to 14 days, which is a CD19-directed CAR T-cell therapy for certain lymphomas. This change, granted to Kite, a Gilead Sciences subsidiary, aims to improve treatment accessibility by offering faster delivery of this personalized therapy. AI Algorithm for Cervical Cancer Screening Hologic's Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm has been FDA approved, introducing the first digital cytology platform integrating AI for cervical cancer screening. This system digitizes traditional Pap test slides, applying AI to enhance detection of pre-cancerous and cancerous cells, improving sensitivity and enabling remote case review. It will be available in the U.S. in early 2024. Trastuzumab Deruxtecan for Solid Tumors The FDA granted priority review to trastuzumab deruxtecan for treating unresectable or metastatic HER2-positive solid tumors, potentially marking it as the first HER2-directed, tumor-agnostic therapy. Based on the DESTINY-PanTumor02 study, showing promising survival outcomes, a decision is expected in the second quarter of 2024. The drug is developed by AstraZeneca and Daiichi Sankyo. -
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Visit nascentmc.com/podcast for full show notesBoxed Warning for CAR-T Cell Therapy: The FDA mandates a boxed warning on all CAR T-cell therapies due to increased secondary cancer risks, affecting six named treatments. This follows investigations into T-cell malignancies in patients treated with BCMA- or CD19-directed therapies. Manufacturers have 30 days to comply or challenge this requirement, reflecting the FDA's stance that benefits still outweigh risks.
Dupilumab for Pediatric EOE: The FDA has approved dupilumab for children aged 1-11 with eosinophilic esophagitis (EoE), expanding from its prior approval for older patients. Dupilumab, targeting interleukin-4 and -13, treats EoE, an allergic inflammation causing symptoms like heartburn and difficulty swallowing. The approval, based on the EoE KIDS trial, marks the first FDA-approved EoE treatment for this age group.
Wearable Device for Osteopenia: The FDA has cleared Osteoboost, a wearable belt for treating osteopenia, marking a non-drug medical device approach in this field. Developed by Bone Health Technologies, it uses low-intensity vibrations on the spine and hip, inspired by NASA's bone loss prevention methods. Clinical trials show its effectiveness in maintaining bone health, and it was reviewed under the FDA’s De Novo process with Breakthrough Device Designation.
BSI-082 IND for Solid and Liquid Tumors: The FDA approved an IND application for BSI-082, a novel antibody targeting SIRPα and β to enhance tumor-associated macrophages' phagocytic activity. Developed by Biosion USA, Inc., BSI-082 covers over 90% of human populations and avoids broad toxicity typical in CD47-targeting therapies. Its in vivo efficacy, especially when combined with other antibodies, shows significant anti-tumor effects in animal models.
VCA-894A for Charcot Marie-Tooth: The FDA approved an IND application for VCA-894A by Vanda Pharmaceuticals to treat Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S). VCA-894A, an antisense oligonucleotide, targets the IGHMBP2 gene variant responsible for CMT2S. CMT2S, a rare condition with symptoms like muscle weakness and sensory impairment, currently has no available treatments; this approval represents a significant step in addressing this genetic disorder.
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Erdafitinib for Urothelial Carcinoma: The FDA has fully approved erdafitinib (Balversa) for advanced or metastatic urothelial carcinoma with FGFR3 genetic alterations in adults. This follows its initial accelerated approval and is based on the phase 3 THOR trial results, showing improved survival rates and manageable side effects. Erdafitinib reduced death risk by 36% and had a lower treatment discontinuation rate compared to chemotherapy. TTFields in NSCLC: The FDA is reviewing a premarket approval application for tumor treating fields (TTFields) combined with standard therapies for platinum-resistant non–small cell lung cancer. TTFields, first approved in 2011, disrupt cancer cell division and showed enhanced survival in NSCLC patients when combined with immune checkpoint inhibitors or docetaxel, without increasing systemic toxicities. The FDA's decision is expected in the second half of 2024. AI-Powered Device to Detect Skin Cancer: The FDA has approved the first AI-powered handheld device by DermaSensor for assisting in skin cancer detection. It uses AI-driven spectroscopy for analyzing skin lesions and is based on a study involving over 1000 patients. While not a primary screening tool, it aids in detecting melanoma and other skin cancers, especially in patients over 40, and requires further validation testing. Casgevy for Transfusion-Dependent Beta Thalassemia: The FDA has approved Casgevy (exa-cel), developed by Vertex Pharmaceuticals and CRISPR Therapeutics, for treating transfusion-dependent beta-thalassemia. This follows its approval for sickle cell disease and marks the first CRISPR gene-editing technology application for this condition. The approval came ahead of the anticipated date and follows Bluebird Bio's 2022 approval for a similar gene therapy. HyQvia for CIDP: HyQvia, an immune globulin infusion 10%, has been approved by the FDA for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. Initially approved for primary immunodeficiency, HyQvia is the only product combining immunoglobulin with hyaluronidase, allowing for monthly subcutaneous infusions. The approval is based on its demonstrated efficacy in preventing neuromuscular disability relapse. Physicians' Understanding of FDA Approval Process: A national survey reveals that many physicians have limited understanding of the FDA's drug and medical device approval processes. Only 41% of the surveyed physicians reported moderate or better comprehension of the drug approval process. Despite believing in the adequacy of FDA standards, there's a call for more rigorous post-marketing studies and enhanced education on FDA processes to avoid misconceptions and inaccurate patient advice.
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See full write up and supporting links for this episode at nascentmc.com/podcast.Summary:
§ FDA has approved berdazimer topical gel, 10.3% (Zelsuvmi), as the first novel drug for molluscum contagiosum, a viral skin infection affecting adults and children over 1 year old.
§ Pembrolizumab (Keytruda) is now approved for stage III-IVA cervical cancer treatment in combination with chemoradiotherapy, based on positive data from the KEYNOTE-A18 trial. It's the third indication for cervical cancer and 39th overall
§ The FDA issued a drug safety communication regarding GLP-1 receptor agonists and suicidal thoughts, finding no clear relationship between them.
§ BrainSee, a noninvasive test, approved for predicting progression from amnestic mild cognitive impairment (aMCI) to Alzheimer's dementia using MRI and cognitive assessments, offering a same-day alternative to traditional methods.
§ SH-105, a novel treatment for breast and ovarian cancers, had its NDA accepted with a target action date set for June 29, 2024, offering a differentiated injectable product.
§ Medtronic's Percept RC deep brain stimulation system received FDA approval for Parkinson's.
§ NexoBrid, a topically administered biological product for burn treatment, expanded its label to include pediatric patients based on positive results from clinical trials.
§ The FDA approved the Teneo excimer laser platform for LASIK surgery, featuring high-speed eye tracking and fast ablation times for precise vision correction in individuals aged 22 and older.
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Nascentmc.comToday’s episode: FDA approves first state request to import drugs from Canada: The FDA has approved Florida's request to import certain drugs from Canada, marking the first time a state has been authorized to buy lower-cost medications in bulk from abroad.
https://www.cnn.com/2024/01/05/politics/florida-canada-drug-imports-fda/index.html
https://www.flgov.com/2024/01/05/florida-becomes-first-in-the-nation-to-have-canadian-drug-importation-program-approved-by-fda/· 5 FDA decisions to watch for:
o Donanemab from Eli Lilly, if approved, could be a significant Alzheimer's treatment, with Phase 3 trial results showing substantial cognitive and functional decline slowing.
o Resmetirom, an oral thyroid hormone receptor agonist, manufactured by Madrigal Pharmaceuticals showed promise in addressing nonalcoholic steatohepatitis (NASH), a leading cause of liver transplantation.
o Sotatercept, acquired by Merck, is being evaluated for treating pulmonary arterial hypertension (PAH) based on promising results from the Phase 3 STELLAR trial.
o Lifileucel, in a phase 3 trial for melanoma, is the first tumor-infiltrating lymphocyte (TIL) therapy for advanced melanoma. FDA's decision on lifileucel is expected by mid-February, and it offers potential as a one-time cell therapy for solid tumor cancer.
o Odronextamab, developed by Regeneron Pharmaceuticals, could become the first bispecific antibody approved for both FL and DLBCL, common non-Hodgkin lymphoma subtypes.
This content was independently written by Dr. Emma Hitt Nichols, but the idea for the 5 upcoming drugs came from this article https://www.biopharmadive.com/news/5-fda-approval-decisions-watch-first-quarter-2024/703377
Use Your Scientific or Medical Background in Medical Editing & Factchecking so you can supplement your income while working from anywhere on your own schedule. Visit learnAMAstyle.com for a free step-by-step checklist.Get immediate medical writing assistance from experienced, excellent, native-English speaking MD- and PhD-medical writers.
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Summary:
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Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of ThemSee the full write ups for today's episode at nascentmc.com/podcast
A summary of Eleven Potentially Practice-Changing Drugs Approved by the FDA in 2023
https://www.pharmacytimes.com/view/eleven-potentially-practice-changing-drugs-were-approved-by-the-fda-in-2023Also added Casgevy and Lyfgenia for Sickle Cell Disease
Podcast episode was from December 11, 2023.Happy new year!
Intro and outro music
Garden Of Love by Pk jazz Collective
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Here are the highlights:
Test for Risk of Opioid Addiction:
The FDA has approved AvertD by SOLVD Health, a test for assessing opioid addiction risk in individuals over 18, using genetic variants to evaluate addiction risk before prescribing oral opioids for acute pain; however, it's met with skepticism and not intended for chronic pain patients.https://www.cnn.com/2023/12/20/health/opioid-use-disorder-test-avertd/index.html
https://avertdtest.com/
Filsuvez for Junctional Epidermolysis Bullosa:
Filsuvez, a birch triterpenes topical gel, received FDA approval for treating Junctional and Dystrophic Epidermolysis Bullosa (JEB/DEB) in individuals aged 6 months and older, marking the first FDA-approved therapy for JEB's partial thickness wounds and a significant advancement in managing this debilitating skin disorder.
https://resources.chiesiusa.com/Filsuvez/FILSUVEZ_PI.pdfBudesonide for IgA Nephropathy:
Budesonide (Tarpeyo) received full FDA approval for reducing kidney function loss in adults with IgA nephropathy (IgAN), targeting specific antibodies implicated in IgAN based on phase 3 NefIgArd clinical trial data, marking the first FDA approval for IgAN treatment based on kidney function measures.https://www.tarpeyo.com/prescribinginformation.pdf
Eplontersen for hATTR Polyneuropathy:
Eplontersen (Wainua) was approved by the FDA for treating polyneuropathy in adults with hereditary transthyretin-mediated amyloidosis (hATTR-PN), based on the NEURO-TTRansform Phase III trial, and is the only hATTR-PN treatment that can be self-administered via an auto-injector.https://pubmed.ncbi.nlm.nih.gov/37768671/
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217388s000lbl.pdfNRX-101 for Complicated UTI:
The FDA cleared an Investigational New Drug application for NRX-101, a D-cycloserine and lurasidone blend developed by NRx Pharmaceuticals for treating complicated urinary tract infections, with a pending request for Qualified Infectious Disease Product designation.https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-announces-fda-clearance-of-its-investigational-new-drug-ind-application-for-nrx-101-in-the-treatment-of-complicated-urinary-tract-infections-302017523.html?utm_source=pocket_saves
Gefapixant for Chronic Cough:
Merck's gefapixant, a selective antagonist of P2X3 receptors for treating chronic cough, was rejected by the FDA for the second time due to insufficient evidence of effectiveness in treating refractory or unexplained chronic cough in adults.https://www.businesswire.com/news/home/20231220302305/en/Merck-Provides-U.S.-Regulatory-Update-on-Gefapixant
V116 for Invasive Pneumococcal Disease:
Merck's V116, a 21-valent pneumococcal conjugate vaccine, was accepted by the FDA for priority review to prevent invasive pneumococcal disease in adults, based on STRIDE-3 Phase 3 trial data, with a target action date set for June 17, 2024.https://www.merck.com/news/fda-grants-priority-review-to-mercks-new-biologics-license-application-for-v116-an-investigational-21-valent-pneumococcal-conjugate-vaccine-specifically-designed-to-protect-adults
Sotorasib in NSCLC:
Lumakras (sotorasib), already under accelerated approval for KRASG12C-mutated non-small cell lung cancer (NSCLC), faces uncertainty for full FDA approval after an advisory committee voted against it, though it will remain available for clinical use.
https://www.onclive.com/view/codebreak-200-sotorasib-in-second-line-kras-g12c-mutated-nsclcnascentmc.com
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Belzutifan (Welireg) for RCC:
- FDA approved belzutifan (Welireg) for advanced renal cell carcinoma (RCC) following prior treatments with PD-1/PD-L1 inhibitors and VEGF-TKI. Belzutifan is an HIF-2α inhibitor, the first novel therapeutic class for advanced RCC since 2015. Approval based on phase 3 LITESPARK-005 study data, granted to Merck Inc.
Pulse Field Ablation (PFA) system for AFib:
- FDA approved PulseSelect PFA system for atrial fibrillation (Afib) treatment. PFA uses electrical pulses to ablate cardiac tissue without thermal energy, reducing adverse events. Medtronic Inc. received approval.
Roflumilast 0.3% (Zoryve) for Seborrheic Dermatitis:
- FDA approved roflumilast foam 0.3% (Zoryve) for seborrheic dermatitis in individuals aged 9 and older. This is the first drug with a new mechanism of action for seborrheic dermatitis in over two decades. Approval supported by positive results from the STRATUM phase 3 trial, granted to Arcutis Biotherapeutics, Inc.
Eflornithine (Iwilfin) for Neuroblastoma:
- FDA approved eflornithine (Iwilfin) to reduce the risk of relapse in high-risk neuroblastoma patients. Eflornithine inhibits ornithine decarboxylase, reducing cell growth. Approval based on multi-site study results and granted to US WorldMeds, LLC.
Isavuconazonium Sulfate For Pediatric Patients:
- FDA approved isavuconazonium sulfate (Cresemba) for invasive aspergillosis and mucormycosis in pediatric patients. Provides an alternative to eye drops for glaucoma treatment, offering continuous delivery of travoprost. Approval based on Phase 3 trials and plans for label change, granted to Glaukos.
Augmented Reality Smart Glasses Technology:
- FDA approved NuLoupes augmented reality smart glasses with 3D stereoscopic imaging for dentistry and medicine. Offers live 3D stereoscopic imaging and plans to ship developer kits in 2024. Approval granted to NuEyes.
OneRF Ablation System for Parkinson’s:
- FDA cleared the OneRF Ablation System for neurosurgical procedures in Parkinson's disease and other neurological conditions. Designed to capture electrical activity and selectively destroy brain tissue. Launch planned by NeuroOne in the first half of 2024.
Pimicotinib For Tenosynovial Giant Cell Tumor:
- FDA granted fast track approval to pimicotinib for the treatment of tenosynovial giant cell tumors. Demonstrated an overall response rate of 87.5% in a Phase 1b trial. Manufactured by Abbisko and commercialized in partnership with Merck.
NDA for MDMA-Assisted Therapy for PTSD:
- NDA submitted for MDMA in combination with psychotherapy for PTSD, aiming to be the first psychedelic-assisted therapy approved for PTSD. Submission by MAPS Public Benefit Corporation based on positive Phase 3 clinical trial results. Requested Priority Review of the NDA.
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