Industry News Drugs.com – New Drug Approvals FDA Approves Penpulimab-kcqx for the Treatment of Advanced Nasopharyngeal CarcinomaApril 24, 2025 Dupixent (dupilumab) Approved in the U.S. as the First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria (CSU)April 18, 2025 U.S. Food and Drug Administration Updates Camzyos (mavacamten) Label to Reduce Echocardiography Monitoring Requirements and ContraindicationsApril 17, 2025 FDA Grants Isturisa (osilodrostat) Expanded Indication for the Treatment of Endogenous Hypercortisolemia in Patients with Cushing’s SyndromeApril 16, 2025 Neurelis Announces FDA Approval for Immediate Use Seizure Medication Valtoco (diazepam nasal spray) in Ages 2 to 5 YearsApril 16, 2025 Mirum’s Livmarli Now FDA Approved in Tablet FormulationApril 14, 2025 FDA Grants Interchangeable Designation to Yuflyma (adalimumab-aaty), Celltrion's Biosimilar to Humira (adalimumab)April 14, 2025 FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) as a First-Line Treatment for Unresectable or Metastatic Hepatocellular CarcinomaApril 11, 2025 FDA Approves Jobevne (bevacizumab-nwgd), a Biosimilar to AvastinApril 10, 2025 Argenx Announces FDA Approval of Vyvgart Hytrulo Prefilled Syringe for Self-InjectionApril 10, 2025 Drugs.com – New Drug Applications 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 DiseaseApril 3, 2025 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 Drugs.com – Clinical Trials News Bristol Myers Squibb Announces Topline Results from Phase 3 ARISE Trial Evaluating Cobenfy (xanomeline and trospium chloride) as an Adjunctive Treatment to Atypical Antipsychotics in Adults with SchizophreniaApril 22, 2025 Orforglipron Demonstrated Statistically Significant Efficacy Results and a Safety Profile Consistent with Injectable GLP-1 Medicines in Successful Phase 3 TrialApril 17, 2025 BlueRock Therapeutics Announces Publication in Nature of 18-Month Data from Phase 1 Clinical Trial for Bemdaneprocel, an Investigational Cell Therapy for Parkinson’s DiseaseApril 16, 2025 Repurposing Blood Pressure Drug Reserpine May Prevent Vision Loss in Inherited Blinding DiseasesApril 15, 2025 Precision BioSciences Receives U.S. FDA Fast Track Designation for PBGENE-HBV, a First-In-Class Gene Editing Therapy Designed to Eliminate the Root Cause of Chronic Hepatitis BApril 15, 2025 Click Therapeutics Announces FDA Marketing Authorization for CT-132, the First Prescription Digital Therapeutic for the Preventive Treatment of Episodic Migraine in the United StatesApril 15, 2025 Bristol Myers Squibb Provides Update on Camzyos Phase 3 ODYSSEY-HCM TrialApril 14, 2025 Ironwood Pharmaceuticals Provides Clinical and Regulatory Update on ApraglutideApril 14, 2025 Pfizer Discontinues Development of Oral GLP-1 Receptor Agonist DanuglipronApril 14, 2025 Novo Nordisk Warns Consumers About Counterfeit Ozempic (semaglutide) Injection 1 mg in the USApril 14, 2025
