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...
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 warns Soulaire Corp. that it is marketing an external counterpulsation system for unapproved uses, adulterating and misbranding the unit.
FDA warns the Telangana, India-based Natco Pharma manufacturing facility about CGMP violations in its production of finished drugs.
CDER establishes the Center for Clinical Trial Innovation to support innovative approaches to clinical trials that are designed to improve the quality...
A federal court sentences former Decision Diagnostics CEO Keith Berman to seven years in prison for a securities fraud scheme involving a Covid-detect...
FDA issues a safety alert on unsafe counterfeit versions of AbbVies Botox (botulinum toxin) have been found in multiple states and administered to con...
