Denali Therapeutics and Calico Life Sciences say their two eukaryotic initiation factor 2B activator drugs each failed to meet primary and secondary e...
FDA publishes a draft guidance with recommendations on lifecycle management and marketing submissions for AI-enabled medical device software functions...
FDA publishes a draft guidance intended to improve the representation of females in medical product clinical trials.
FDA requires safety labeling changes about Guillain-Barr syndrome risks for Pfizers Abrysvo (respiratory syncytial virus vaccine) and GlaxoSmithKline ...
FDA approves Ionis Spinraza as the first drug approved to treat children and adults with spinal muscular atrophy.
FDA approves Array BioPharmas Braftovi to treat some patients with metastatic colorectal cancer with a specific mutation.
FDA posts a draft guidance entitled Considerations for Including Tissue Biopsies in Clinical Trials.
FDA releases a draft guidance entitled Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-Making for Drug and B...
