The House Oversight and Reform Committee schedules two days of hearings on drug prices with testimony from executives of six companies.
Federal Register notice: FDA proposes to withdraw approval of five ANDAs because the application holders have repeatedly failed to file required annua...
After FDA commissioner Stephen Hahn assured Congress that FDAs review and approval/authorization of a Covid-19 vaccine would be based on data and scie...
FDA releases the FDA-483 with three observations from an inspection at Front Range Laboratories.
FDA announces a two-day (10/15-16) public Webinar on New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment.
FDA says it now recommends that people in seven high-risk categories refrain from exposure to dental mercury amalgam when possible.
Prompted by TikTok-posted teenager challenges, a new FDA safety alert warns that taking higher than recommended doses of Benadryl (diphenhydramine) ca...
FDA grants Leap Therapeutics a fast track designation for DKN-01 and its use in treating certain patients with gastric and gastroesophageal junction a...