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FDA publishes a draft guidance with its recommendations for menstrual product performance testing and labeling.
FDA posts a seven-item Form FDA-483 after inspecting Dr. Reddys Mirfield, West Yorkshire, UK, active pharmaceutical ingredient manufacturing facility ...
Intellia Therapeutics pauses two Phase 3 trials of nex-z, a CRISPR-based therapy for transthyretin amyloidosis with cardiomyopathy and polyneuropathy,...
A Senate Committee demands answers from HHS on what they describe as serious national security and public health risks tied to Americas dependence on ...
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.
