FDA warns Innocore Sales & Marketing in Woodstock, Ontario, Canada, about CGMP violations in its production of finished drugs.
FDA names acting Office of New Drugs (OND) director Mary Tran Thanh-Hai as the new OND director, replacing previous head Peter Stein.
Three Hyman, Phelps & McNamara attorneys notice that FDA has provided a 30-day response time instead of the usual 15 days for two medical device compa...
FDA publishes a draft guidance with its recommendations for menstrual product performance testing and labeling.
BridgeBio reports positive Phase 3 data for BBP-418 in limb-girdle muscular dystrophy patients as it plans an NDA filing in second quarter next year.
FDA releases a draft guidance outlining recommendations for medical device manufacturers on the type of Quality Management System information to inclu...
FDA posts a six-item Form FDA-483 after inspecting Hetero Labs Vishakapatnam, India, warehouse last month.
FDA approves an expanded indication for Mercks pulmonary arterial hypertension therapy Winrevair (sotatercept-csrk), clearing the drug to reduce the r...
