United States Food and Drug Administration
Sarepta Discontinues Development of SRP-5051 for Duchenne Muscular Dystrophy Due to Safety Concerns
Sarepta Therapeutics, SRP-5051, Duchenne muscular dystrophy, DMD, safety concerns, hypomagnesemia, FDA, clinical trials
Sarepta Therapeutics Halts Development of Vesleteplirsen, a Next-Generation Exon-Skipping Therapy for Duchenne Muscular Dystrophy
Sarepta Therapeutics, Vesleteplirsen (SRP-5051), Duchenne Muscular Dystrophy (DMD), Exon-Skipping Therapy, FDA Feedback, Therapeutic Landscape
FDA Authorizes LumiThera’s Valeda Light Delivery System for Dry AMD Treatment
FDA authorization, Valeda Light Delivery System, dry AMD treatment, photobiomodulation, LumiThera
FDA Mandates Enhanced Safety Warnings for CAR-T Therapies Due to Secondary Cancer Risks
CAR-T therapy, secondary cancers, FDA boxed warnings, T-cell malignancies, BCMA-directed, CD19-directed, autologous CAR T-cell immunotherapies.
Vertex’s CASGEVY Marks Historic Milestone with First Commercial Patient Infusions, Paving the Way for 2025 Launches
CASGEVY, Vertex Pharmaceuticals, gene therapy, sickle cell disease, beta thalassemia, CRISPR/Cas9, FDA approval, commercial patient infusions, 2025 launches.
FDA Delays Decision on Merus’ Zenocutuzumab for NRG1+ Lung and Pancreatic Cancer
Zenocutuzumab, NRG1+ cancer, FDA delay, Merus, lung cancer, pancreatic cancer, bispecific antibody.
Dr. Reddy’s Recalls Over 300,000 Bottles of Thyroid Medication Due to Carcinogen Contamination
Dr. Reddy’s, thyroid drug recall, carcinogen contamination, pharmaceutical safety, FDA regulations
FDA Raises Sterility and Quality Concerns at Mark Cuban’s Dallas Drug Compounding Facility
Mark Cuban, Cost Plus Drugs, FDA, sterility concerns, quality issues, drug compounding, Dallas facility
Journey Medical’s Emrosi Receives FDA Approval, Setting New Standard for Rosacea Treatment
Rosacea treatment, Emrosi, FDA approval, Minocycline hydrochloride, Journey Medical Corporation, Dermatological conditions, New standard of care
FDA Advisory Committee Rejects Lexicon’s Zynquista for Type 1 Diabetes and Chronic Kidney Disease
FDA, Lexicon Pharmaceuticals, Zynquista, sotagliflozin, type 1 diabetes, chronic kidney disease, FDA advisory committee, drug approval