concerns
AstraZeneca Addresses Safety Concerns Over Andexxa, Discontinues Opioid Use Disorder Drug
AstraZeneca, Andexxa, FDA, Safety Concerns, Anticoagulation Reversal, Opioid Use Disorder, AZD4041
FDA Panel Raises Safety Concerns Over AstraZeneca’s Anticoagulant Reversal Drug Andexxa
AstraZeneca, Andexxa, FDA panel, anticoagulant reversal drug, safety concerns, full approval
FDA Raises Safety Concerns Over AstraZeneca’s Andexxa Ahead of Advisory Committee Meeting
AstraZeneca, Andexxa, FDA, safety concerns, bleeding reversal agent, advisory committee meeting
Neurogene’s Rett Syndrome Gene Therapy Shows Efficacy but Raises Safety Concerns
Neurogene, Rett syndrome, gene therapy, NGN-401, AAV vector, clinical trial, safety concerns, efficacy results
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
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
Tyra Biosciences Unveils Early Data for FGFR3 Inhibitor, TYRA-300, in Challenge to J&J’s Balversa
Tyra Biosciences, TYRA-300, Balversa, J&J, bladder cancer, urothelial carcinoma, FGFR3 inhibitor, safety concerns, efficacy data
Novo Nordisk Seeks FDA Ban on Compounded Semaglutide Formulations Amid Safety Concerns
Novo Nordisk, FDA, semaglutide, compounding pharmacies, safety concerns, GLP-1 medications, weight loss drugs, diabetes treatments
FDA Halts Kezar’s Lupus Nephritis Trial Due to Safety Concerns Following Four Patient Deaths
FDA, Kezar Life Sciences, lupus nephritis, zetomipzomib, clinical hold, patient deaths, safety 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