Cautionary Warning
Sarepta Shifts Focus to siRNA Platform, Lays Off 500 After Elevidys Receives Black Box Warning
Sarepta Therapeutics; siRNA platform; Elevidys; Duchenne muscular dystrophy; layoffs; black box warning; pipeline shift; acute liver injury; gene therapy; restructuring
Applied Therapeutics’ Rare Disease Drug Fails Another Phase 3 Trial After FDA Rejection
Applied Therapeutics; govorestat; rare disease; phase 3 failure; FDA rejection; classic galactosemia; aldose reductase inhibitor; clinical trial conduct; FDA warning letter
FDA Issues Boxed Warning for Anaphylaxis Risk with Multiple Sclerosis Drugs Copaxone and Glatopa
FDA, boxed warning, anaphylaxis, multiple sclerosis, Copaxone, Glatopa, glatiramer acetate, Teva, Sandoz
FDA Adds Boxed Warning to Teva’s Copaxone and Generic Glatopa Due to Anaphylaxis Risk
FDA Boxed Warning, Anaphylaxis Risk, Copaxone, Glatopa, Glatiramer Acetate, Multiple Sclerosis (MS) Treatment, Allergic Reaction
Sanofi Assures No Supply Disruptions Following FDA Warning Letter for US Manufacturing Site
Sanofi, FDA warning letter, US manufacturing site, supply interruptions, CGMP deviations
FDA Mandates Guillain-Barré Syndrome Warning for Pfizer and GSK RSV Vaccines
RSV vaccines, Guillain-Barré syndrome, FDA warning, Pfizer, GSK, Abrysvo, Arexvy
FDA Updates Label for Agios’ PYRUKYND with New Liver Injury Warning
Agios Pharmaceuticals, PYRUKYND, mitapivat, liver injury warning, FDA label update, thalassemia treatment
FDA Warns of Serious Liver Injury Risk with Ocaliva (Obeticholic Acid) in Patients with Primary Biliary Cholangitis
Ocaliva, obeticholic acid, liver injury, FDA warning, primary biliary cholangitis, liver disease, medication safety
Ocaliva (Obeticholic Acid) Linked to Increased Risk of Liver Failure in PBC Patients Without Cirrhosis
Ocaliva, obeticholic acid, primary biliary cholangitis (PBC), liver failure, liver injury, cirrhosis, FDA warning.
UK Health Secretary Warns Against Misuse of GLP-1 Weight Loss Drugs for Aesthetic Purposes
GLP-1 agonists, weight loss drugs, misuse, aesthetic weight loss, UK health secretary, MHRA warnings