FDA publishes a draft guidance aimed at increasing the enrollment of females in clinical trials of drugs and medical devices.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.
FDA warns San Diego, CA-based Microvascular Tissue about CGMP violations in its production and marketing of an unapproved new drug that is also an unl...
In a recent interview, FDA commissioner Marty Makary positions himself as a supporter of vaccines while defending recent agency actions that have draw...
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 ...
Vanda Pharmaceuticals files a BLA for imsidolimab and its use in treating generalized pustular psoriasis, a rare and potentially fatal inflammatory sk...
FDA proactively awards Johnson & Johnson a national priority voucher for teclistamab in combination with daratumumab for treating relapsed or refracto...
