Industry News Drugs.com – New Drug Approvals FDA Approves Differin Epiduo Acne Gel (adapalene/benzoyl peroxide) for Nonprescription Use in the Treatment of AcneMay 24, 2026 Datroway Approved in the U.S. as First TROP2 Directed Antibody Drug Conjugate for First-Line Treatment of Patients with Metastatic Triple Negative Breast Cancer Who Are Not PD-1/PD-L1 Inhibitor CandidatesMay 22, 2026 FDA Grants Accelerated Approval to Hepcludex (bulevirtide-gmod) Treatment for Chronic Hepatitis Delta Virus (HDV)May 22, 2026 FDA Approves Baxfendy (baxdrostat) as the First Aldosterone Synthase Inhibitor Treatment for Adults with HypertensionMay 18, 2026 FDA Approves Trimbow (beclomethasone/formoterol/glycopyrrolate) Inhaler for the Maintenance Treatment of AsthmaMay 18, 2026 FDA Approves Immgolis Intri (golimumab-sldi), an Interchangeable Biosimilar to Simponi Aria (golimumab)May 17, 2026 FDA Approves Immgolis (golimumab-sldi), an Interchangeable Biosimilar to SimponiMay 17, 2026 FDA Approves Genentech’s Tecentriq for Adjuvant Muscle-Invasive Bladder Cancer With ctDNA-Guided TreatmentMay 15, 2026 Enhertu Approved in the US for Two New Indications for Patients with HER2 Positive Early Breast CancerMay 15, 2026 Fasenra Approved in US for Hypereosinophilic SyndromeMay 14, 2026 Drugs.com – New Drug Applications U.S. FDA Grants Priority Review of New Drug Application for Gilead’s Once-Daily HIV Treatment of Bictegravir Plus LenacapavirApril 29, 2026 Immunome Announces Submission of New Drug Application to U.S. FDA for Varegacestat for the Treatment of Adults with Desmoid TumorsApril 28, 2026 U.S. Food and Drug Administration Accepts New Drug Application for Zipalertinib for the Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion MutationsApril 28, 2026 Bepirovirsen Accepted for Priority Review and Granted Breakthrough Therapy Designation by the US FDAApril 28, 2026 Intellia Therapeutics Initiates Rolling Submission of Biologics License Application to FDA for Lonvoguran Ziclumeran (lonvo-z) as a One-Time Treatment for Hereditary AngioedemaApril 26, 2026 Belite Bio Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt DiseaseApril 20, 2026 Replimune Receives Complete Response Letter from the FDA for RP1 Biologics License Application for the Treatment of Advanced MelanomaApril 10, 2026 FDA Accepts NDA for TLX101-Px (Pixclara®)April 10, 2026 Nuvalent Announces Submission of New Drug Application to FDA for Neladalkib in TKI Pre-treated Advanced ALK-Positive NSCLCApril 7, 2026 Ultragenyx Announces U.S. FDA Acceptance of BLA Resubmission for UX111 AAV Gene Therapy to Treat Sanfilippo Syndrome Type A (MPS IIIA)April 2, 2026 Drugs.com – Clinical Trials News NIH Researchers Identify Avenue for Enhanced GLP-1-Induced Weight LossMay 22, 2026 Foundayo (orforglipron) was Associated with Reduced Body Weight of Up To 13% in Adults 65 and Older with Obesity or Overweight, in New Analysis of ATTAIN-1/2May 22, 2026 Biogen and Denali Therapeutics Provide Update on Phase 2b LUMA Study of BIIB122 (DNL151) in Early-Stage Parkinson’s DiseaseMay 21, 2026 Lilly's Triple Agonist, Retatrutide, Delivered Powerful Weight Loss in Pivotal Phase 3 Obesity TrialMay 21, 2026 ATS: Phase 2 Data Demonstrate the Superiority of Efdoralprin Alfa Over a Standard-of-Care Augmentation Therapy in Achieving Higher fAAT levels in AATDMay 18, 2026 Merck Announces TroFuse-005 Trial Evaluating Sacituzumab Tirumotecan (Sac-TMT) Met Primary Endpoints of Overall Survival (OS) and Progression-Free Survival (PFS) in Certain Patients With Advanced or Recurrent Endometrial CancerMay 18, 2026 Regeneron Provides Update on Phase 3 Trial of Fianlimab (LAG-3 Inhibitor) Combination in First-Line Unresectable or Metastatic MelanomaMay 15, 2026 Topline Results from Phase 2 CELIA Study of Diranersen (BIIB080): First Study to Show Reduction in Tau Pathology and Cognitive Benefit in Patients with Early Alzheimer’s DiseaseMay 14, 2026 Researchers Identify First Suite of Human Antibodies Against Measles VirusMay 14, 2026 Wegovy Pill Delivered 21.6% Weight Loss in Early Responders and Doubled Mobility Improvement, According to New Novo Nordisk Data at ECO2026May 13, 2026
