Industry News Drugs.com – New Drug Approvals ADMA Biologics Announces FDA Approval to Expand the Label for Asceniv to Include Pediatric Immune Compromised Patients Two Years of Age and OlderMay 4, 2026 FDA Approves Langlara (insulin glargine-aldy), an Interchangeable Biosimilar to LantusMay 4, 2026 Incyte Announces FDA Approval of Jakafi XR (ruxolitinib) Extended-Release Tablets for the Treatment of Myelofibrosis, Polycythemia Vera and Graft-Versus-Host DiseaseMay 1, 2026 FDA Approves Veppanu (vepdegestrant) for the Treatment of ESR1m, ER+/HER2- Advanced Breast CancerMay 1, 2026 Axsome Therapeutics Announces FDA Approval of Auvelity (dextromethorphan HBr and bupropion HCl) for the Treatment of Agitation Associated with Dementia due to Alzheimer’s DiseaseApril 30, 2026 Breztri Approved in the US for Asthma as First and Only Triple Therapy for Patients 12 Years of Age and OlderApril 28, 2026 Saphnelo Approved in the US for Subcutaneous Self-Administration as a New Autoinjector for the Treatment of Systemic Lupus ErythematosusApril 27, 2026 FDA Approves Caplyta (lumateperone) sNDA with Robust New Data Supporting Reduced Risk of Relapse in SchizophreniaApril 27, 2026 FDA Grants Accelerated Approval for Otarmeni (lunsotogene parvec-cwha) Gene Therapy for Genetic Hearing LossApril 23, 2026 Sanofi's Tzield Approved in the U.S. to Delay the Onset of Stage 3 Type 1 Diabetes in Young ChildrenApril 22, 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 29, 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 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 Orca Bio Announces FDA Review Extension of BLA for Orca-T for the Treatment of Hematologic MalignanciesApril 1, 2026 Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in Gastrointestinal Stromal Tumors (GIST)April 1, 2026 Elevar Therapeutics Announces FDA Acceptance for Review of New Drug Application for Lirafugratinib as Second-line Cholangiocarcinoma TreatmentMarch 30, 2026 Drugs.com – Clinical Trials News Takeda Announces Positive Topline Results from Pivotal Phase 2/3 Clinical Trial of TAK-881 in Primary Immunodeficiency Disease (PID)May 4, 2026 Revolution Medicines Statement on FDA Expanded Access Authorization for Daraxonrasib in Patients with Previously Treated Metastatic Pancreatic CancerMay 1, 2026 Update on FDA Advisory Committee Vote on Camizestrant in Combination with a CDK4/6 Inhibitor for Advanced HR-Positive Breast CancerApril 30, 2026 Adding Weekly GLP-1 to Cognitive Behavioral Therapy Further Reduces Heavy DrinkingApril 30, 2026 Denecimig (Mim8) Significantly Reduced Annualised Bleeding Rate in People with Hemophilia A, Regardless of Inhibitor Status, in Phase 3 Data Published in NEJMApril 29, 2026 Boehringer Ingelheim’s Novel Glucagon/GLP-1 Dual Agonist Survodutide Achieved Significant Weight Loss and Meaningful Metabolic Improvement in Phase III TrialApril 28, 2026 GSK’s Investigational Liver Therapy, Efimosfermin, Receives US FDA Breakthrough Therapy and EMA Priority Medicines (PRIME) Designations for MASHApril 27, 2026 Symptom-Based Approach Treats Opioid Withdrawal in Newborns with Minimal Drug ExposureApril 27, 2026 CDER Proposes to Withdraw Approval of TavneosApril 27, 2026 Clinical Trial Finds No Difference in Fluid Treatment Options for Pediatric SepsisApril 24, 2026
