concerns
FDA Raises Concerns Over Stealth BioTherapeutics’ Ultra-Rare Disease Drug Ahead of Advisory Committee Meeting
FDA, Stealth BioTherapeutics, elamipretide, Barth syndrome, ultra-rare disease, advisory committee meeting, drug approval, efficacy concerns
Kezar Life Sciences Suspends Enrollment and Dosing in Phase 2b PALIZADE Trial Due to Safety Concerns
Kezar Life Sciences, PALIZADE trial, zetomipzomib, lupus nephritis, safety concerns, patient deaths, clinical trial halt
Pfizer Withdraws Sickle Cell Disease Treatment Oxbryta Globally Due to Safety Concerns
Pfizer, Oxbryta, sickle cell disease, global market withdrawal, safety concerns, clinical trials, vaso-occlusive crises, fatal events
Novo Nordisk’s CB1 Drug Monlunabant Shows Weight Loss Potential, but Raises Efficacy and Safety Concerns
Novo Nordisk, Monlunabant, CB1 receptor, obesity treatment, weight loss, efficacy, safety concerns, neuropsychiatric side effects
FDA Advisory Committee Votes Against Ocaliva for Primary Biliary Cholangitis Due to Safety Concerns
Ocaliva, FDA, Primary Biliary Cholangitis, Liver Disease, Safety Concerns, Advisory Committee Vote
Roche’s Obesity Pill Candidate Faces Safety Concerns Amid Promising Efficacy Results
Roche, Obesity Pill, Safety Concerns, Efficacy Data, CT-996, Side Effects, Nausea, Vomiting, Gastrointestinal Issues
Autoimmune CAR-Ts Under Scrutiny Following Cabaletta’s Safety Concerns in Lupus Treatment
Autoimmune CAR-T, Cabaletta, Lupus, Safety Concerns, Clinical Trials
FDA Rejects Rocket Pharmaceuticals’ Gene Therapy for Ultra-Rare Immune Disease Over Manufacturing Concerns
FDA, Rocket Pharmaceuticals, Gene Therapy, Leukocyte Adhesion Deficiency-I (LAD-I), Manufacturing Concerns
FDA Rejects Merck-Daiichi’s HER3-Targeted ADC Due to Manufacturing Issues
FDA, Merck, Daiichi Sankyo, HER3-targeted ADC, patritumab deruxtecan, manufacturing concerns, lung cancer treatment
FDA Halts BioNTech-MediLink ADC Trial Due to ‘Significant Risk of Illness or Injuries’
FDA, BioNTech, MediLink, ADC, Clinical Trial, Safety Concerns, Cancer Treatment