Industry News Drugs.com – New Drug Approvals FDA Approves Ekterly (sebetralstat) the First and Only Oral On-demand Treatment for Hereditary Angioedema (HAE)July 8, 2025 FDA Grants Accelerated Approval to Lynozyfic (linvoseltamab-gcpt) for Treatment of Relapsed or Refractory Multiple MyelomaJuly 2, 2025 FDA Grants Accelerated Approval to Zegfrovy (sunvozertinib) for Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion MutationsJuly 2, 2025 Takeda Announces U.S. FDA Approval of Gammagard Liquid ERC, the Only Ready-to-Use Liquid Immunoglobulin Therapy with Low Immunoglobulin A (IgA) ContentJune 30, 2025 FDA Approves Gamifant (emapalumab-lzsg) as First-Ever Treatment for Adults and Children with Macrophage Activation Syndrome in Still's DiseaseJune 28, 2025 U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb’s Cell Therapy Labels for Breyanzi and AbecmaJune 26, 2025 Emmaus Life Sciences Receives FDA Approval for Endari Label EnhancementsJune 26, 2025 FDA Approves Benlysta (belimumab) Autoinjector for Children with Active Lupus NephritisJune 24, 2025 FDA Approves Expanded Indications for GE HealthCare’s Vizamyl PET Imaging Agent for Beta Amyloid Detection, Enabling More Precise Care for Alzheimer’s PatientsJune 24, 2025 Datroway Approved in the U.S. as First TROP2 Directed Therapy for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung CancerJune 23, 2025 Drugs.com – New Drug Applications Unicycive Therapeutics Announces Receipt of Complete Response Letter for Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on DialysisJune 30, 2025 Achieve Life Sciences Announces Submission of NDA to FDA for Cytisinicline as a Treatment of Nicotine Dependence for Smoking CessationJune 26, 2025 Aldeyra Therapeutics Resubmits Reproxalap New Drug Application for the Treatment of Dry Eye DiseaseJune 17, 2025 KalVista Pharmaceuticals Announces FDA Will Not Meet PDUFA Goal Date for Sebetralstat NDA for Hereditary Angioedema Due to FDA Resource ConstraintsJune 13, 2025 Tenpoint Therapeutics Ltd. Announces FDA Acceptance of New Drug Application for Brimochol PF for the Treatment of PresbyopiaJune 3, 2025 Linerixibat New Drug Application (NDA) Accepted for Review by the US FDA for Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (PBC)June 2, 2025 Kura Oncology and Kyowa Kirin Announce FDA Acceptance and Priority Review of New Drug Application for Ziftomenib in Adults with Relapsed or Refractory NPM1-Mutant AMLJune 1, 2025 U.S. FDA Accepts New Drug Application Under Priority Review for Sevabertinib (BAY 2927088) in HER2-Mutant Non-Small Cell Lung CancerMay 29, 2025 Stealth BioTherapeutics Announces “Path Forward” Despite Disappointing Delay for Ultra-Rare Barth SyndromeMay 29, 2025 Patritumab Deruxtecan Biologics License Application for Patients with Previously Treated Locally Advanced or Metastatic EGFRMutated Non-Small Cell Lung Cancer Voluntarily WithdrawnMay 29, 2025 Drugs.com – Clinical Trials News Apogee Therapeutics Announces Positive 16-Week Data from Phase 2 APEX Clinical Trial of APG777, its Potentially Best-in-Class Anti-IL-13 Antibody, in Moderate-to-Severe Atopic DermatitisJuly 7, 2025 Hemispherian Receives U.S. FDA Orphan Drug Designation for GLIX1 for the Treatment of Malignant GliomaJuly 1, 2025 Amgen Announces Positive Topline Phase 3 Results for Bemarituzumab in Fibroblast Growth Factor Receptor 2b (FGFR2b) Positive First-line Gastric CancerJune 30, 2025 Breast Cancer Risk in Younger Women May Be Influenced by Hormone TherapyJune 30, 2025 UCB Announces Positive Results from GEMZ Phase 3 Study of Fenfluramine in CDKL5 Deficiency DisorderJune 27, 2025 Edgewise Therapeutics Reports Positive Results on Sevasemten Program for Becker and Duchenne Muscular DystrophiesJune 26, 2025 Riliprubart Earns Orphan Drug Designation in the US for Antibody-Mediated Rejection in Solid Organ TransplantationJune 25, 2025 Stuart Therapeutics Announces Initial Results of Phase III Clinical Trial for ST-100 (Vezocolmitide) Ophthalmic Solution, a Novel Dry Eye Disease CandidateJune 24, 2025 Perfuse Therapeutics Announces Positive Results from Phase 2 Clinical Trials of PER-001 in Glaucoma and Diabetic Retinopathy PatientsJune 24, 2025 Rivus Pharmaceuticals Announces Positive Topline Results from Phase 2 M-ACCEL Trial of HU6 Showing Significant Reductions in Liver Fat in Patients with MASHJune 24, 2025
