Industry News Drugs.com – New Drug Approvals FDA Grants Accelerated Approval to Emrelis (telisotuzumab vedotin-tllv) for Non-Small Cell Lung Cancer With High c-Met Protein OverexpressionMay 14, 2025 FDA Approves Merck’s Welireg (belzutifan) for the Treatment of Adults and Pediatric Patients 12 Years and Older With Locally Advanced, Unresectable, or Metastatic Pheochromocytoma or Paraganglioma (PPGL)May 14, 2025 FDA Grants Accelerated Approval to Avmapki Fakzynja Co-Pack (avutometinib capsules/defactinib tablets) for KRAS-Mutated Recurrent Low-Grade Serous Ovarian CancerMay 8, 2025 Teva and Alvotech Announce FDA Approval of Interchangeability for Selarsdi (ustekinumab-aekn) with Stelara (ustekinumab)May 5, 2025 FDA Approves Imaavy (nipocalimab-aahu) for the Treatment of Generalized Myasthenia Gravis (gMG)April 30, 2025 FDA Approves Atzumi (dihydroergotamine) Nasal Powder for the Acute Treatment of MigraineApril 30, 2025 Rinvoq (upadacitinib) Receives U.S. FDA Approval for Giant Cell Arteritis (GCA)April 29, 2025 FDA Approves Zevaskyn (prademagene zamikeracel) Gene Therapy for Patients with Recessive Dystrophic Epidermolysis BullosaApril 29, 2025 FDA Approves Penpulimab-kcqx for the Treatment of Advanced Nasopharyngeal CarcinomaApril 24, 2025 Dupixent (dupilumab) Approved in the U.S. as the First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria (CSU)April 18, 2025 Drugs.com – New Drug Applications FDA Extends PDUFA Date of Biohaven's Troriluzole NDA for Rare Disease Spinocerebellar AtaxiaMay 14, 2025 Vanda Announces Bysanti NDA Filing; FDA Decision Expected in Early 2026May 5, 2025 Cytokinetics Announces New PDUFA Date for Aficamten in Obstructive Hypertrophic CardiomyopathyMay 1, 2025 Stealth BioTherapeutics Announces Delay in FDA Action Date for Barth Syndrome Application for ElamipretideApril 29, 2025 Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Signs and Symptoms of Dry Eye DiseaseApril 3, 2025 Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti for the Treatments of Acute Bipolar I Disorder and SchizophreniaMarch 31, 2025 Otsuka Files Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A NephropathyMarch 31, 2025 FDA Issues Complete Response Letter for Etripamil for PSVTMarch 28, 2025 FDA Grants Priority Review for Biologics License Application (BLA) for Apitegromab as a Treatment for Spinal Muscular AtrophyMarch 25, 2025 Tolebrutinib Regulatory Submission Accepted for Priority Review in the US for Patients with Multiple SclerosisMarch 25, 2025 Drugs.com – Clinical Trials News The New England Journal of Medicine Publishes Data from Phase 2b Trial of Oral Orexin Receptor 2 Agonist Oveporexton (TAK-861) in People with Narcolepsy Type 1May 14, 2025 In New SELECT Trial Analysis, Early Reduction in Cardiovascular Events Was Observed with Wegovy®, Before Clinically Meaningful Changes in Body WeightMay 13, 2025 Zepbound (tirzepatide) Showed Superior Weight Loss Over Wegovy (semaglutide) in Complete SURMOUNT-5 Results Published in The New England Journal of MedicineMay 11, 2025 Akero Therapeutics Announces Publication of Phase 2b SYMMETRY Trial of Efruxifermin in the New England Journal of MedicineMay 9, 2025 Icotrokinra Results Show Significant Skin Clearance in Patients with Difficult-to-Treat Scalp and Genital PsoriasisMay 9, 2025 GLISTEN Phase III Trial Results Show Linerixibat Significantly Improves Cholestatic Pruritus in Primary Biliary CholangitisMay 8, 2025 Final Data From the Phase 3 MYR301 Study Demonstrated Longer Treatment With Bulevirtide Was Associated With Sustaining Undetectability After Stopping TreatmentMay 7, 2025 Boehringer Ingelheim Starts Phase II Study of BI 1584862, Potential First-in-Class Oral Compound as a Treatment for Geographic AtrophyMay 6, 2025 Aldeyra Therapeutics Achieves Primary Endpoint in Phase 3 Dry Eye Disease Chamber Trial of Reproxalap and Plans NDA ResubmissionMay 5, 2025 Alterity Therapeutics Granted U.S. FDA Fast Track Designation for ATH434 to Treat Multiple System AtrophyMay 5, 2025
