Safety
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
Novartis’ $2.9B MorphoSys Acquisition Hits Roadblock as Safety Concerns Delay Approval Filing
Novartis, MorphoSys, safety signal, delayed approval, biotech, pharmaceuticals
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
Bavarian Nordic’s Mpox Vaccine Demonstrates Equivalent Efficacy in Teens and Adults: NIH Study
Mpox vaccine, Bavarian Nordic, MVA-BN vaccine, Teenagers, Adults, Antibody response, Safety, Efficacy, NIH study
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
Comparative Efficacy of J&J’s Erleada and Astellas/Pfizer’s Xtandi in Non-Metastatic Prostate Cancer: Real-World Study Insights
Prostate Cancer, Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC), Erleada (Apalutamide), Xtandi (Enzalutamide), Real-World Study, Comparative Efficacy, Safety Profiles
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