Industry News Drugs.com – New Drug Approvals FDA Approves Zanvastro (zilganersen) to Treat Alexander DiseaseSeptember 3, 2026 FDA Approves PharmaEssentia’s BESREMi (ropeginterferon alfa-2b-njft) for Adults with Essential ThrombocythemiaAugust 31, 2026 FDA Approves Mimrylo (rusfertide) for the Treatment of Polycythemia VeraAugust 28, 2026 FDA Approves Bixlenvo (bictegravir and lenacapavir) for the Treatment of HIV in Adults Who Are Virologically SuppressedAugust 28, 2026 FDA Approves Stelara for Pediatric Ulcerative ColitisAugust 28, 2026 FDA Approves Lilly's Mounjaro (tirzepatide) to Reduce Cardiovascular Risk in Adults with Type 2 DiabetesAugust 27, 2026 Moderna Receives U.S. FDA Approval for Updated 2026-2027 Spikevax and mNEXSPIKE COVID-19 VaccinesAugust 27, 2026 Pfizer and BioNTech Receive U.S. FDA Approval for XFG-Adapted Comirnaty COVID-19 VaccineAugust 27, 2026 FDA Approves Lisraya (brepocitinib) for the Treatment of Adults with DermatomyositisAugust 27, 2026 FDA Approves Rasonque (daraxonrasib), the First Broad RAS-Targeted Medicine in Metastatic Pancreatic CancerAugust 26, 2026 Drugs.com – New Drug Applications Capricor Therapeutics Announces Extension of PDUFA Target Action Date as FDA Continues Review of Deramiocel BLAAugust 24, 2026 United Therapeutics Corporation Announces FDA Filing Acceptance of New Drug Application for Ralinepag to Treat Pulmonary Arterial HypertensionAugust 24, 2026 Xspray Pharma receives Complete Response Letter (CRL) from FDA for DasynocAugust 19, 2026 U.S. FDA Accepts Teva’s New Drug Application (NDA) and Grants Priority Review for Ecopipam, a First-in-Class Investigational Therapy for Pediatric Patients with Tourette SyndromeAugust 19, 2026 Belite Bio Announces U.S. Food and Drug Administration Acceptance and Priority Review of New Drug Application for Tinlarebant for the Treatment of Stargardt Disease Type 1August 10, 2026 Scholar Rock Announces FDA Review of Apitegromab Biologics License Application (BLA) for Spinal Muscular Atrophy (SMA) to Progress with Second Fill-Finish FacilityAugust 7, 2026 Saol Therapeutics Announces the Acceptance of Resubmission of SL1009 (DCA) by the FDA with PDUFA Date of Dec. 30, 2026July 27, 2026 Revolution Medicines’ New Drug Application for Daraxonrasib Accepted for Review by U.S. FDA for Previously Treated Metastatic Pancreatic CancerJuly 21, 2026 BridgeBio Announces FDA Acceptance of NDA for Encaleret for ADH1July 21, 2026 Camurus’ NDA Resubmission for CAM2029 in Acromegaly Accepted for Review by the US FDAJuly 16, 2026 Drugs.com – Clinical Trials News AbbVie Announces Positive Topline Results from the Phase 3 CERVINO Trial Showing Etentamig Significantly Improved Response Rate and Progression-Free Survival in Patients with Relapsed/Refractory Multiple MyelomaSeptember 3, 2026 Ultragenyx Announces Phase 3 Aspire Results for Apazunersen (GTX-102) in Angelman SyndromeSeptember 2, 2026 Teva Announces Positive Topline Results from Phase 2a Study of TEV ‘408 in Celiac Disease for Its Anti-IL-15 Antibody, Further Validating Its Pipeline-in-a-Product PotentialSeptember 2, 2026 Novartis Remibrutinib, a High-Efficacy Oral BTK Inhibitor, Significantly Reduces Relapse Rates and Shows Favorable Safety Profile in Phase III RMS TrialsSeptember 1, 2026 Juniper’s JBS-003 (F-MISO) Program Receives FDA Breakthrough Therapy Designation, Advancing a First-in-Class Hypoxia Tracer Enabling Radiation De-escalation in HPV-Positive Head and Neck CancerSeptember 1, 2026 NIH Researchers Identify Rare Antibodies with Potential to Combat Alpha-Gal SyndromeSeptember 1, 2026 BioNTech Provides Update on Phase 2 Clinical Trial of Autogene Cevumeran in Resected Colorectal CancerAugust 27, 2026 CytomX Therapeutics Announces FDA Fast Track Designation for Varsetatug masetecan (“Varseta-M”) for Relapsed/Refractory Metastatic Colorectal Cancer (R/R mCRC)August 27, 2026 JAMA Dermatology Publishes Skin-Specific Outcomes from Phase 3 VALOR Trial Of Brepocitinib in DermatomyositisAugust 26, 2026 Zepbound Linked to Lower Healthcare Costs in Adults Over Age 55 with Obesity According to a Real-World StudyAugust 26, 2026
