FDA posts a draft guidance entitled Considerations for Including Tissue Biopsies in Clinical Trials.
FDA releases a draft guidance entitled Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-Making for Drug and B...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...
FDA approves Galdermas Nemluvio to treat some dermatitis patients aged 12 and older.
FDA says Alcon recalled one lot of Systane Ultra PF eye drops due to potential fungal contamination.
FDA approves Array BioPharmas Braftovi to treat some patients with metastatic colorectal cancer with a specific mutation.
FDA says Endo USA has recalled its Adrenalin Chloride Solution that predates the Federal Food, Drug, and Cosmetic Act and was never submitted for FDA ...