Industry News Drugs.com – New Drug Approvals FDA Approves Gomekli (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PNFebruary 11, 2025 FDA Approves Emblaveo (aztreonam and avibactam) for the Treatment of Adults With Complicated Intra-Abdominal InfectionsFebruary 7, 2025 FDA Approves Onapgo (apomorphine hydrochloride) for the Treatment of Motor Fluctuations in Adults with Advanced Parkinson’s DiseaseFebruary 4, 2025 FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Treatment of Diabetic Macular EdemaFebruary 4, 2025 FDA Approves Symbravo (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in AdultsJanuary 31, 2025 FDA Approves Avtozma (tocilizumab-anoh), a Biosimilar to ActemraJanuary 30, 2025 FDA Approves Journavx (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute PainJanuary 30, 2025 FDA Approves Ozempic (semaglutide) as the Only GLP-1 RA to Reduce the Risk of Worsening Kidney Disease and Cardiovascular Death in Adults with Type 2 Diabetes and Chronic Kidney DiseaseJanuary 28, 2025 Enhertu Approved as First HER2-Directed Therapy for Patients with HER2-Low or HER2-Ultralow Metastatic Breast CancerJanuary 28, 2025 FDA Approves Leqembi (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer’s DiseaseJanuary 27, 2025 Drugs.com – New Drug Applications Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple MyelomaFebruary 11, 2025 Scholar Rock Submits Biologics License Application (BLA) to the U.S. FDA for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA)January 29, 2025 Saol Therapeutics Announces FDA Acceptance of New Drug Application for SL1009 for Treatment of Pyruvate Dehydrogenase Complex DeficiencyJanuary 28, 2025 Stealth BioTherapeutics Announces PDUFA Action Date Extension for Elamipretide to Treat Patients with Barth SyndromeJanuary 23, 2025 Arrowhead Pharmaceuticals Announces Acceptance of New Drug Application by U.S. FDA of Plozasiran for the Treatment of Familial Chylomicronemia SyndromeJanuary 17, 2025 Atara Biotherapeutics Provides Regulatory and Business Update on Ebvallo (tabelecleucel)January 16, 2025 U.S. FDA Granted Priority Review to Dizal's Sunvozertinib New Drug ApplicationJanuary 7, 2025 Capricor Therapeutics Completes Submission of Biologics License Application to the U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular DystrophyJanuary 2, 2025 Verastem Oncology Announces FDA Acceptance and Priority Review of New Drug Application for Avutometinib in Combination with Defactinib for the Treatment of Recurrent KRAS Mutant Low-Grade Serous Ovarian CancerDecember 30, 2024 NRx Pharmaceuticals, Inc. Files Initial Section of U.S. New Drug Application to the FDA for NRX-100 (IV Ketamine) for the Treatment of Suicidal DepressionDecember 30, 2024 Drugs.com – Clinical Trials News Single Dose of Broadly Neutralizing Antibody Protects Macaques from H5N1 InfluenzaFebruary 11, 2025 NIH-Funded Clinical Trial Will Evaluate New Dengue TherapeuticFebruary 11, 2025 Boehringer’s Nerandomilast Meets Primary Endpoint in Phase III Study FIBRONEER™-ILD, in Progressive Pulmonary FibrosisFebruary 10, 2025 Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Moderate-to-Severe Atopic DermatitisFebruary 10, 2025 Eledon Pharmaceuticals Announces Use of Tegoprubart as Key Component of Immunosuppression Regimen in its Second Transplant of a Genetically Modified Pig Kidney into a HumanFebruary 7, 2025 Pliant Therapeutics Provides Update on BEACON-IPF, a Phase 2b/3 Trial of Bexotegrast in Patients with Idiopathic Pulmonary FibrosisFebruary 7, 2025 Lipella Pharmaceuticals Granted FDA Approval for Expanded Access Program for LP-310 in Oral Lichen PlanusFebruary 6, 2025 Merck Announces Phase 3 waveLINE-010 Trial Initiation Evaluating Zilovertamab Vedotin, an Investigational Antibody-Drug Conjugate, for the Treatment of Patients With Previously Untreated Diffuse Large B-Cell LymphomaFebruary 6, 2025 Allarity Therapeutics Announces Expansion of Phase 2 Clinical Trial to Accelerate Development of Stenoparib in Advanced Ovarian CancerFebruary 6, 2025 Bracco Imaging Receives FDA Fast Track Designation for BR55February 6, 2025