Hemorrhage
FDA Rejects Full Approval for AstraZeneca’s Andexxa Amid Safety Concerns
Andexxa, AstraZeneca, FDA, full approval, safety concerns, bleeding reversal agent, FXa inhibitors
FDA Raises Safety Concerns Over AstraZeneca’s Andexxa Ahead of Advisory Committee Meeting
AstraZeneca, Andexxa, FDA, safety concerns, bleeding reversal agent, advisory committee meeting
Pfizer and Sangamo’s Gene Therapy Shows Superiority Over Prophylaxis in Hemophilia A Study
Pfizer, Sangamo, gene therapy, hemophilia A, prophylaxis, giroctocogene fitelparvovec, bleeding rate, Factor VIII
Pfizer’s Hemophilia A Gene Therapy Candidate Achieves Phase 3 Success
Pfizer, Hemophilia A, Gene Therapy, Phase 3 Trial, Giroctocogene Fitelparvovec, Bleeding Rate Reduction
FDA Unexpectedly Postpones Approval Decision for Eli Lilly’s Donanemab, Schedules AdComm Review
Donanemab, Eli Lilly, FDA delay, Approval postponement, Peripheral and Central Nervous System Drugs Advisory Committee (PCNS), Safety and efficacy review, Clinical trial results, Brain swelling and bleeding side effects, Accelerated approval declined, Leqembi and Aduhelm precedent, Full approval anticipated, Accelerated approval rejected.