FDA plans to publish a proposed rule by the end of the year that would require prescription drug advertisements on television, radio and similar broad...
FDA looks to formalize one of its most significant transparency initiatives in decades: the public release of Complete Response Letters issued to comp...
FDA sends Lundbeck Seattle Biopharmaceuticals an untitled letter alleging that promotional materials for its migraine therapy Vyepti (eptinezumab-jjmr...
FDA releases the draft MDUFA performance goals and procedures approved by CDRH and CBER for the 2027 renewal of MDUFA that will cover FY 2028-2032.
Former FDAer David Elder recommends that companies qualify AI tools to assist them in preparing for and responding to FDA inspections.
FDA releases the form FDA-483 with three observations from an inspection at the QuVa Pharma outsourcing facility in Sugar Land, TX.
FDA grants Vera Therapeutics an accelerated approval for Trutakna (atacicept-vymj) to reduce proteinuria in adults with primary immunoglobulin A nephr...
FDA warns that the LyfeUnit Web site is selling unapproved adulterated and misbranded ketamine products.
