FDA commissioner Stephen Hahn and CBER director Peter Marks strongly urge healthcare providers not to unilaterally alter the FDA-authorized dosing sch...
FDA releases its latest batch of Warning Letters that include Cocos Holistic Specialties & Apothecary and Reddy Naturals.
FDA issues a guidance with the latest provisions of the Q-Submission program for medical devices agreed to under MDUFA 4.
Bristol-Myers Squibb decides to end its Opdivo development program for treating some brain cancer patients.
Operation Warp Speed is spending $356 million for doses of a Merck drug to treat severe Covid-19 patients.
Attorney Joanne Hawana reviews FDA Covid-related drug and biologic actions in 2020, praising the agency for its transparency in issuing emergency auth...
FDA approves Amphastars generic glucagon for injection to treat severe hypoglycemia in diabetics.
FDA authorizes Interscopes EndoRotor system for resecting and removing necrotic tissue for patients with walled-off pancreatic necrosis undergoing a d...