FDA commissioner Marty Makary says the agency has no plans to add a Black Box Warning to Covid vaccines, contradicting a report from last week saying ...
FDA warns Little Rock, AR-based 3D Imaging Drug Design and Development about CGMP and listing violations in its production of positron emission tomogr...
FDA extends the review of Aldeyra Therapeutics NDA resubmission for reproxalap, pushing back a regulatory decision on the investigational dry eye dise...
FDA publishes a draft guidance aimed at increasing the enrollment of females in clinical trials of drugs and medical devices.
President Trump appoints Yale epidemiologist Harvey Risch to chair the Presidents Cancer Panel, a move that is raising alarm among cancer researchers ...
FDA releases the form FDA-483 with seven observations from an inspection at the Exton, PA-based ProRx outsourcing facility.
Sanofi says it will not seek FDA approval for tolebrutinib in primary progressive multiple sclerosis after the drug failed to meet its primary endpoin...
FDA says it is removing a long-standing barrier to the use of real-world evidence in regulatory reviews by accepting such data without requiring ident...
