FDA warns Mesquite, TX-based Strukmyer Medical about CGMP violations in manufacturing finished drugs and cosmetics.
FDA warns Chinas Chengdu Innovation Pharmaceutical Co. about CGMP deviations in manufacturing active pharmaceutical ingredients.
DC federal judge John Bates orders FDA and CDC to re-post Web pages and datasets they removed to comply with President Trumps executive order on gende...
A STAT First Opinion column calls on FDA to focus on how effective new antibiotics are in real-world patients, rather than approving them based on how...
FDA accepts for priority review a Biohaven NDA for troriluzole for treating adult patients with spinocerebellar ataxia.
FDA grants Guerbet a Breakthrough Device Designation for LipioJoint, a liquid embolic agent designed to alleviate pain in patients with knee osteoarth...
FDA approves a SpringWorks Therapeutics NDA for Gomekli (mirdametinib) for treating certain patients with neurofibromatosis Type 1.
FDA accepts for review a Regeneron Pharmaceuticals BLA resubmission for linvoseltamab for treating adult patients with relapsed/refractory multiple my...
