Novartis asks FDA to impose limits on applications for generic forms of its Lutathera radioligand.
FDA issues Sun Pharmaceutical Industries a six-item Form-483 following a two-week December inspection at the firms Dadra, Dadra & Nagar Haveli and Dam...
FDA releases the form FDA-483 with three observations from an inspection at a Eugia Steriles drug manufacturing facility in Andhra Pradesh, India, the...
FDA posts its official notice that Oncopeptides accelerated-approval multiple myeloma drug Pepaxto (melphalan flufenamide) has been withdrawn after fa...
FDA denies a Hyman, Phelps & McNamara petition seeking permission to submit an ANDA for generic Imodium with two different strengths than the referenc...
CDRH releases reports on its commitment to medical device innovation and safety.
Boston Scientific recalls its embolic agent Obsidio Embolic after an investigation finds that its use with the aliquot technique for lower gastrointes...
Sen. Bill Cassidy says FDA needs to explain why it ignored Congress and expanded its oversight over clinical decision support software.
