An FDA-authored journal article signals a supportive but cautious regulatory posture toward the development of chimeric antigen receptor T-cell therap...
FDA issues an early alert to warn clinicians about a potentially high-risk issue affecting certain Abiomed heart pump devices used to support patients...
HHS Office of Inspector General begins an ethics investigation into FDA deputy chief of staff Samuel Doran and whether he misled the federal governmen...
Floridas FDA-authorized drug importation program stalls and has yet to deliver any imported medicines more than two years after receiving final agency...
FDA issues Beta Bionics a Warning Letter following an inspection of the companys Irvine, CA, facility conducted 6/2025.
FDA issues Pharming Group a complete response letter for its supplemental NDA seeking expanded approval of Joenja (leniolisib) for children aged 4 to ...
FDA sends Aquestive Therapeutics a complete response letter for its NDA for Anaphylm, a sublingual epinephrine film for treating Type I allergic react...
A patient safety advocacy group files a citizen petition urging FDA to create a comprehensive public database of medical device labels.
