FDA publishes a draft guidance intended to improve the representation of females in medical product clinical trials.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FDA publishes a draft guidance on developing drugs for optical imaging for three purposes.
FDA accepts for priority review a Dizal NDA for sunvozertinib, an oral EGFR inhibitor for treating locally advanced or metastatic non-small cell lung ...
FDA posts a draft guidance entitled Considerations for Including Tissue Biopsies in Clinical Trials.
FDA releases a draft guidance entitled Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-Making for Drug and B...
Neumora Therapeutics says its Phase 3 KOASTAL-1 Study of navacaprant for treating major depressive disorder missed its primary endpoint and a key seco...
CDER approves 50 novel products in 2024, five less than the 55 products approved in 2023 and well above the 10-year rolling annual average of 46 appro...