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 Array BioPharmas Braftovi to treat some patients with metastatic colorectal cancer with a specific mutation.
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 Ionis Spinraza as the first drug approved to treat children and adults with spinal muscular atrophy.
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 ...
FDA warns four companies it says are marketing unapproved copies of popular weight loss drugs.
FDA publishes an updated Global Unique Device Identification Database guidance.