Industry News Drugs.com – New Drug Approvals U.S. FDA Approves Label Update to Accelerate Thaw Time for Adstiladrin (nadofaragene firadenovec-vncg)March 24, 2026 Bristol Myers Squibb Transforms the Classical Hodgkin Lymphoma Treatment Paradigm with Expanded U.S. Approval for Opdivo (nivolumab)March 20, 2026 FDA Approves Novo Nordisk’s New Wegovy HD Injection, Delivering the Highest Weight Loss to Date for a Wegovy InjectionMarch 19, 2026 FDA Approves Lynavoy (linerixibat) for Cholestatic Pruritus in Patients with Primary Biliary CholangitisMarch 19, 2026 Rhythm Pharmaceuticals Announces FDA Approval of Imcivree (setmelanotide) for Patients with Acquired Hypothalamic ObesityMarch 19, 2026 FDA Approves Icotyde (icotrokinra) for the Treatment of Plaque PsoriasisMarch 18, 2026 Novartis Cosentyx Receives FDA Approval for Pediatric Patients Aged 12+ with Moderate to Severe Hidradenitis SuppurativaMarch 13, 2026 GSK’s RSV Vaccine, Arexvy, Approved in US for Expanded Age Indication in Adults Aged 18–49 Years at Increased RiskMarch 13, 2026 FDA Approves Expanded Use of Wellcovorin (leucovorin calcium) for Patients with Cerebral Folate Transport DeficiencyMarch 10, 2026 U.S. FDA Approves Bristol Myers Squibb’s Sotyktu (deucravacitinib) for the Treatment of Adults with Active Psoriatic ArthritisMarch 6, 2026 Drugs.com – New Drug Applications Ionis Announces Zilganersen New Drug Application for Alexander Disease (AxD) Accepted by FDA for Priority ReviewMarch 17, 2026 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 DiseaseMarch 17, 2026 Cogent Biosciences Announces FDA Acceptance of New Drug Application for Bezuclastinib in Patients with NonAdvanced Systemic Mastocytosis (NonAdvSM)March 16, 2026 Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara) Brain Cancer Imaging CandidateMarch 16, 2026 Capricor Therapeutics Announces Establishment of New PDUFA Date for Deramiocel BLAMarch 10, 2026 Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia VeraMarch 2, 2026 Xspray Pharma Re-Submits its FDA Application for DasynocFebruary 26, 2026 Beren Therapeutics Announces FDA Acceptance of its New Drug Application for Adrabetadex in Infantile-Onset Niemann Pick Disease Type CFebruary 23, 2026 Garetosmab Biologics License Application Accepted for FDA Priority Review for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP)February 19, 2026 FDA Accepts New Drug Application for Genentech’s Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast CancerFebruary 19, 2026 Drugs.com – Clinical Trials News Pfizer and Valneva Announce Lyme Disease Vaccine Candidate PF-07307405 (LB6V) Demonstrates Strong Efficacy in Phase 3 VALOR TrialMarch 23, 2026 Lilly's Triple Agonist, Retatrutide, Demonstrated Significant Reductions in A1C and Weight in First Phase 3 Trial for Treatment of Type 2 DiabetesMarch 19, 2026 Sanofi’s Venglustat Earns Breakthrough Therapy Designation in the US for Type 3 Gaucher DiseaseMarch 18, 2026 Pfizer Announces Positive Topline Phase 2 Results for Next-Generation CDK4 Inhibitor, Atirmociclib, in Second-Line Metastatic Breast CancerMarch 17, 2026 Argo Biopharma Receives FDA Fast Track Designation for BW-20805, an Investigational siRNA Therapy for the Treatment of HAEMarch 16, 2026 Clinical Trial Results Support Use of Weekly Extended-Release Buprenorphine for Treatment of Opioid Use Disorder During PregnancyMarch 16, 2026 Biogen Presents Additional Salanersen Data Showing New Motor Milestones Achieved in Children with SMA Previously Treated with Gene TherapyMarch 11, 2026 Vertex Announces Positive Week 36 Interim Analysis Results for Primary and All Secondary Endpoints in the RAINIER Phase 3 Trial of Povetacicept in Adults With IgA NephropathyMarch 9, 2026 AbbVie Announces Positive Topline Results from a Phase 1 Multiple Ascending Dose Study of ABBV-295, a Long-Acting Amylin Analog, in AdultsMarch 9, 2026 Ipsen Voluntarily Withdraws Tazverik (tazemetostat) in Follicular Lymphoma and Epithelioid SarcomaMarch 9, 2026
