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FDA releases the form FDA-483 with three observations from an inspection at a Eugia Steriles drug manufacturing facility in Andhra...[ Price : $8.95]
FDA posts its official notice that Oncopeptides accelerated-approval multiple myeloma drug Pepaxto (melphalan flufenamide) has bee...[ Price : $8.95]
FDA denies a Hyman, Phelps & McNamara petition seeking permission to submit an ANDA for generic Imodium with two different strengt...[ Price : $8.95]
CDRH releases reports on its commitment to medical device innovation and safety.[ Price : $8.95]
Boston Scientific recalls its embolic agent Obsidio Embolic after an investigation finds that its use with the aliquot technique f...[ Price : $8.95]
Sen. Bill Cassidy says FDA needs to explain why it ignored Congress and expanded its oversight over clinical decision support soft...[ Price : $8.95]
Fresenius Kabi USA recalls its Ivenix Infusion Systems pump software due to a necessary software update.[ Price : $8.95]
Eli Lilly plans to file an NDA mid-year for tirzepatide and its use in treating obstructive sleep apnea; the drug is currently mar...