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official notice that Oncopeptides accelerated-approval multiple myeloma drug Pepaxto (melphalan flufenamide) has been withdrawn after fa...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.
Fresenius Kabi USA recalls its Ivenix Infusion Systems pump software due to a necessary software update.
Eli Lilly plans to file an NDA mid-year for tirzepatide and its use in treating obstructive sleep apnea; the drug is currently marketed as Zepbound fo...
