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 warns Indias Bhargava Phytolab about CGMP issues in its manufacturing of finished drugs and active pharmaceutical ingredients.
FDA recommends that companies making transmucosal buprenorphine drugs indicated to treat opioid dependence revise the labeling to indicate there is no...
FDA approves Neurocrine Biosciences Crenessity to be used with glucocorticoids to control androgen in adult and some pediatric patients with classic c...
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 ...