Industry News Drugs.com – New Drug Approvals FDA Approves Merilog (insulin-aspart-szjj), a Biosimilar to NovoLogFebruary 16, 2025 FDA Approves Xbryk (denosumab-dssb), a Biosimilar to XgevaFebruary 16, 2025 FDA Approves Ospomyv (denosumab-dssb), a Biosimilar to ProliaFebruary 16, 2025 FDA Approves Penmenvy (meningococcal groups A, B, C, W, and Y vaccine) for Prevention of Invasive Meningococcal Disease Caused by Serogroups A, B, C, W, and YFebruary 15, 2025 FDA Approves Vimkunya (chikungunya vaccine, recombinant) for Prevention of Disease Caused by Chikungunya VirusFebruary 14, 2025 FDA Approves Romvimza (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell TumorFebruary 14, 2025 U.S. FDA Approves Expanded Label for Astellas' Izervay (avacincaptad pegol intravitreal solution) for Geographic AtrophyFebruary 12, 2025 U.S. FDA Approves Pfizer’s Adcetris Combination Regimen for the Treatment of Relapsed/Refractory Diffuse Large B-Cell LymphomaFebruary 12, 2025 FDA Approves Genentech’s Evrysdi Tablet as First and Only Tablet for Spinal Muscular Atrophy (SMA)February 12, 2025 FDA Approves Gomekli (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PNFebruary 11, 2025 Drugs.com – New Drug Applications PTC Therapeutics Announces FDA Acceptance and Priority Review for Vatiquinone NDA for the Treatment of Children and Adults with Friedreich's AtaxiaFebruary 19, 2025 Chimerix Announces FDA Acceptance and Priority Review of New Drug Application for Dordaviprone as Treatment for Recurrent H3 K27M-Mutant Diffuse GliomaFebruary 18, 2025 Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application for the Treatment of Spinocerebellar AtaxiaFebruary 11, 2025 Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple MyelomaFebruary 11, 2025 LIB Therapeutics Announces FDA Acceptance of Biologics License Application for Lerodalcibep to Lower LDL-Cholesterol Across Broad Patient PopulationFebruary 10, 2025 FDA Grants Priority Review to Insmed's Brensocatib for Treatment of Bronchiectasis with PDUFA Target Action Date Set for August 12, 2025February 6, 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 Drugs.com – Clinical Trials News Clarity Receives US FDA Fast Track Designation for the Treatment of Metastatic Castration-Resistant Prostate Cancer Patients with Cu-67 SAR-bisPSMAFebruary 19, 2025 Boehringer’s Zongertinib Receives Priority Review from U.S. FDA for the Treatment of HER2 (ERBB2)-Mutant Advanced Non-Small Cell Lung CancerFebruary 19, 2025 Innate Pharma Announces U.S. FDA Granted Breakthrough Therapy Designation to Lacutamab for Relapsed or Refractory Sézary SyndromeFebruary 17, 2025 FDA Grants Fast Track Designation to PleoPharma, Inc's Investigational New Drug, PP-01, for the Mitigation of Cannabis Withdrawal Symptoms in Patients With Cannabis Use DisorderFebruary 13, 2025 Lundbeck’s Potential Treatment Amlenetug for Multiple System Atrophy Receives Fast Track Designation From the FDAFebruary 12, 2025 Single Dose of Broadly Neutralizing Antibody Protects Macaques from H5N1 InfluenzaFebruary 11, 2025 NIH-Funded Clinical Trial Will Evaluate New Dengue TherapeuticFebruary 11, 2025 Spinogenix Completes Phase 2 Study of SPG601 for Treatment of Fragile X Syndrome, a Common Inherited Form of Autism, Showing Strong Efficacy Signal in Measures of Abnormal Brain ActivityFebruary 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
