FDA warns Mexicos Unomedical Device about Quality System and Medical Device Reporting violations in its production of insulin infusion sets.
FDA issues an early alert to warn clinicians about a potentially high-risk issue affecting certain Abiomed heart pump devices used to support patients...
FDA grants AstraZeneca and Daiichi Sankyo a priority review for their antibodydrug conjugate Datroway (datopotamab deruxtecan) as a potential first-li...
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.
