Industry News Drugs.com – New Drug Approvals Bavarian Nordic Receives U.S. FDA Approval of Jynneos Freeze-Dried Smallpox and Mpox VaccineMarch 31, 2025 FDA Approves Qfitlia (fitusiran) to Treat Hemophilia A or B With or Without InhibitorsMarch 28, 2025 FDA Approves Imfinzi (durvalumab) for Muscle Invasive Bladder CancerMarch 28, 2025 FDA Approves Novartis Radioligand Therapy Pluvicto for Earlier Use Before Chemotherapy in PSMA-Positive Metastatic Castration-Resistant Prostate CancerMarch 28, 2025 FDA Approves Bomyntra (denosumab-bnht), a Biosimilar to XgevaMarch 27, 2025 FDA Approves Conexxence (denosumab-bnht), a Biosimilar to ProliaMarch 27, 2025 Exelixis Announces U.S. FDA Approval of Cabometyx (cabozantinib) for Patients with Previously Treated Advanced Neuroendocrine TumorsMarch 26, 2025 FDA Approves Vykat XR (diazoxide choline) to Treat Hyperphagia in Prader-Willi SyndromeMarch 26, 2025 FDA Approves Blujepa (gepotidacin) for the Treatment of Uncomplicated Urinary Tract InfectionsMarch 25, 2025 Theratechnologies Receives FDA Approval for Egrifta WR (tesamorelin F8) to Treat Excess Visceral Abdominal Fat in Adults with HIV and LipodystrophyMarch 25, 2025 Drugs.com – New Drug Applications Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti for the Treatments of Acute Bipolar I Disorder and SchizophreniaMarch 31, 2025 Otsuka Files Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A NephropathyMarch 31, 2025 FDA Issues Complete Response Letter for Etripamil for PSVTMarch 28, 2025 FDA Grants Priority Review for Biologics License Application (BLA) for Apitegromab as a Treatment for Spinal Muscular AtrophyMarch 25, 2025 Tolebrutinib Regulatory Submission Accepted for Priority Review in the US for Patients with Multiple SclerosisMarch 25, 2025 Capricor Therapeutics Announces FDA Acceptance and Priority Review of its Biologics License Application for Deramiocel to Treat Duchenne Muscular DystrophyMarch 4, 2025 Depemokimab Applications Accepted for Review by the US FDA for Asthma with Type 2 Inflammation and for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)March 3, 2025 FDA Files Corcept’s New Drug Application for Relacorilant as Treatment for Patients With HypercortisolismMarch 3, 2025 Odronextamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Follicular LymphomaFebruary 26, 2025 PTC Therapeutics Announces FDA Acceptance and Priority Review for Vatiquinone NDA for the Treatment of Children and Adults with Friedreich's AtaxiaFebruary 19, 2025 Drugs.com – Clinical Trials News Combination Immunotherapy Shrank a Variety of Metastatic Gastrointestinal CancersApril 1, 2025 Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian CancerMarch 31, 2025 AZD0780, a Novel Oral PCSK9 Inhibitor, Demonstrated Significant LDL Cholesterol (LDL-C) Reduction in PURSUIT Phase IIb TrialMarch 31, 2025 Lilly's Lepodisiran Reduced Levels of Genetically Inherited Heart Disease Risk Factor, Lipoprotein(a), by Nearly 94% from Baseline at the Highest Tested Dose in Adults with Elevated LevelsMarch 30, 2025 Merck’s Investigational Subcutaneous Pembrolizumab With Berahyaluronidase Alfa Demonstrates Noninferior Pharmacokinetics Compared to Intravenous (IV) Keytruda® (pembrolizumab) in Pivotal 3475A-D77 TrialMarch 27, 2025 Chlamydia Vaccine Candidate Granted Fast Track Designation by the US FDAMarch 26, 2025 Palatin’s Oral MC4R Agonist PL7737 Receives FDA Orphan Drug Designation for Obesity Due to Leptin Receptor DeficiencyMarch 25, 2025 The United Laboratories and Novo Nordisk Announce Exclusive License Agreement for UBT251, a GLP-1/GIP/Glucagon Triple Receptor AgonistMarch 24, 2025 NIH Researchers Develop Eye Drops That Slow Vision Loss in AnimalsMarch 21, 2025 Omeros Corporation Provides Update of Ongoing Zaltenibart Phase 3 PNH Clinical Trial ProgramMarch 21, 2025
