United States Food and Drug Administration
FDA Approves Amgen’s Bkemv, First Interchangeable Biosimilar to Soliris for Rare Blood Disorders ###
Bkemv, Soliris, FDA approval, Interchangeable biosimilar, Rare blood disorders, Paroxysmal nocturnal hemoglobinuria (PNH), Atypical hemolytic uremic syndrome (aHUS), Amgen, AstraZeneca, Alexion Pharmaceuticals
Amgen Secures FDA Approval for Bkemv, the First Interchangeable Biosimilar to Soliris for Rare Blood Disorders
FDA approval, Amgen, Bkemv, Soliris, biosimilar, rare blood disorders, paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS)
Insmed’s Stocks Skyrocket Following Triumphant Phase III Results for Brensocatib in Bronchiectasis Treatment
Insmed, brensocatib, bronchiectasis, Phase III trial, lung disease, stock surge, New Drug Application, FDA approval, market value
NS Pharma’s Duchenne Muscular Dystrophy Therapy Viltepso Fails Confirmatory Trial
NS Pharma, Viltepso, Duchenne Muscular Dystrophy, Confirmatory Trial, Phase III, RACER53 Study, FDA Approval
NS Pharma’s Viltepso Fails Confirmatory Phase III Trial for Duchenne Muscular Dystrophy Treatment
Viltepso, NS Pharma, Duchenne muscular dystrophy, RACER53 study, viltolarsen, FDA approval, confirmatory trial, phase III trial, DMD treatment
FDA Grants Approval for First Interchangeable Biosimilars to Regeneron’s Eylea
FDA, biosimilars, interchangeable, Regeneron, Eylea, approval, blockbuster, drug, treatment, eye diseases, macular degeneration, diabetic retinopathy, retinal vein occlusion
FDA Greenlights Biocon Biologics and Biogen’s Eylea Biosimilars: A New Era in Ophthalmology
FDA, Eylea, biosimilars, Biocon Biologics, Biogen, ophthalmology, aflibercept, regulatory approval
Extended Data from Gilead’s PBC Program Strengthens Case Ahead of FDA Ruling
Gilead, PBC Program, FDA Decision, Long-term Data, Primary Biliary Cholangitis
FDA Revokes Accelerated Approval of Helsinn’s Cancer Drug at Company’s Request
FDA, Helsinn, accelerated approval, cancer drug, company request, drug withdrawal, regulatory decision, clinical trials, patient safety.
FDA Rejects Elevar and Hengrui Pharma’s Combination Therapy for Liver Cancer
FDA, Elevar Therapeutics, Hengrui Pharmaceuticals, liver cancer, combination therapy, rejection, clinical trials.