FDA extends expiration dates on some EpiPen lots to help ease product shortage.
JAMA deputy editor Gregory Curfman calls for congressional action to resolve the question of who a consumer can sue when injured by a generic drug tha...
FDA clears a Techlab 510(k) for the H. Pylori Quik Chek and the H. Pylori Chek tests that are intended to aid in diagnosing H. pylori infection.
FDA releases its latest batch of Warning Letters that include Hangzhou Karic Commodities and Kyowa Hakko Bio.
FDA clears a UVision360 510(k) for the Luminelle DTx Hysteroscopy for use in both hysteroscopy and cystoscopy procedures.
FDA grants Audentes Therapeutics a regenerative medicine advanced therapy designation for AT132 and its use in treating X-linked myotubular myopathy.
FDA approves a Merck expanded label for Keytruda in combination with pemetrexed (Alimta) and platinum chemotherapy for first-line treatment of certain...
bioMerieux recalls its Vitek 2 AST P631 after customer reports indicate an increase in the rate of non-detected methicillin-resistant Staphylococcus a...