patient safety
Sarepta Halts Duchenne Gene Therapy in Some Patients After Second Death
Sarepta Therapeutics; gene therapy; Duchenne muscular dystrophy; Elevidys; acute liver failure; non-ambulatory patients; FDA; clinical trial pause; immunosuppression; patient safety
U.S. Hospitals Urge Trump to Exempt Medical Supplies and Pharmaceuticals from New Tariffs
Tariffs, medical supplies, pharmaceuticals, American Hospital Association, China, Mexico, Canada, healthcare costs, supply chain disruption, patient safety
FDA Clears BioNTech-MediLink ADC Trial to Resume with Reduced Doses
BioNTech, MediLink, ADC trial, FDA approval, lower doses, cancer treatment, HER3, patient safety
Novo Nordisk Expands Legal Campaign Against Compounders of GLP-1 Drugs
Novo Nordisk, GLP-1 drugs, compounded drugs, legal campaign, patient safety, semaglutide
FDA Halts vTv Therapeutics’ Type-1 Diabetes Clinical Trial Due to Chromatographic Signal
vTv Therapeutics, FDA, clinical trial, type-1 diabetes, cadisegliatin, chromatographic signal, patient safety, glucokinase activator
Lilly Expands Legal Efforts Against Compounded Tirzepatide Sellers, Warns of Counterfeit Risks
Eli Lilly, tirzepatide, Mounjaro, Zepbound, compounded drugs, counterfeit products, legal actions, patient safety
FDA Places Partial Clinical Hold on Zentalis’ Azenosertib Cancer Studies Following Two Sepsis Deaths
Zentalis Pharmaceuticals, azenosertib, FDA, partial clinical hold, cancer studies, sepsis deaths, WEE1 inhibitor, clinical trials, patient safety
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.