Industry News Drugs.com – New Drug Approvals 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 Dupixent (dupilumab) Approved in the U.S. as the Only Targeted Medicine to Treat Patients with Bullous Pemphigoid (BP)June 20, 2025 FDA Approves Harliku (nitisinone) for the Treatment of Patients with AlkaptonuriaJune 19, 2025 FDA Approves Yeztugo (lenacapavir) as the First and Only HIV Prevention Option Offering 6 Months of ProtectionJune 18, 2025 Incyte Announces FDA Approval of Monjuvi (tafasitamab-cxix) in Combination with Rituximab and Lenalidomide for Patients with Relapsed or Refractory Follicular LymphomaJune 18, 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 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 Riliprubart Earns Orphan Drug Designation in the US for Antibody-Mediated Rejection in Solid Organ TransplantationJune 25, 2025 Nuvalent Announces Positive Pivotal Data from ARROS-1 Clinical Trial of Zidesamtinib for TKI Pre-treated Patients with Advanced ROS1-Positive NSCLCJune 24, 2025 Quoin Pharmaceuticals Announces FDA Grants Rare Pediatric Disease Designation for QRX003 in Netherton SyndromeJune 24, 2025 Results From Amgen's Phase 2 Obesity Study of Monthly MariTide Presented at the American Diabetes Association 85th Scientific SessionsJune 23, 2025 Novo Nordisk's Mim8 Prophylaxis Treatment Shown to be Well-Tolerated When Switching from Emicizumab in People with Hemophilia A in New Phase 3 DataJune 22, 2025 Lilly's Once-Weekly Insulin Efsitora Alfa Demonstrated A1C Reduction and a Safety Profile Consistent with Daily Insulin in Multiple Phase 3 TrialsJune 22, 2025 Lilly's Oral GLP-1, Orforglipron, Showed Compelling Efficacy and a Safety Profile Consistent with Injectable GLP-1 Medicines, in Complete Phase 3 ResultsJune 21, 2025
