Former FDA commissioner Scott Gottlieb says the agency should revert to clinical decision support system regulatory policies approved during his tenur...
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.
