Safety
Controversy Surrounds FDA’s Fast-Track Approval of Sarepta’s Duchenne Muscular Dystrophy Gene Therapy
FDA, Sarepta Therapeutics, Duchenne Muscular Dystrophy (DMD), gene therapy, accelerated approval, controversy, clinical trials, efficacy, safety, patient advocacy, regulatory process.
Barinthus’ HPV Therapy Demonstrates Safety Yet Falls Short in Efficacy
Barinthus, HPV therapy, safety, efficacy, clinical trials, human papillomavirus, vaccine alternatives
FDA Approves Vadadustat (Vafseo) for Anemia in Chronic Kidney Disease Patients on Dialysis and Daprodustat (Jesduvroq) for Dialysis-Dependent CKD Adults
Anemia, Chronic Kidney Disease (CKD), Vadadustat (Vafseo), Daprodustat (Jesduvroq), Oral medication, FDA approval, Hemoglobin levels, Black Box Warning, Efficacy and safety data, Post-marketing safety data
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.
Roche and Alnylam’s Hypertension Hopeful Zilebesiran Shows Promising Results in Combination Therapy Trial
Roche, Alnylam, Zilebesiran, Hypertension, Combination Therapy, Phase 2 Trial, Blood Pressure Control, AngioTensinogen (AGT), RNA Interference (RNAi) Therapeutic, Significant Reductions in Systolic Blood Pressure, Encouraging Safety Profile
FDA rejects Defender’s motion sickness treatment
United States Food and Drug Administration, Safety, Effectiveness