[ Price : $8.95]
Federal Register notice: FDA determines that Janssen Pharmaceuticals Invega (paliperidone) extended-release tablet was not withdra...[ Price : $8.95]
FDA converts Janssens Sirturo (bedaquiline) from accelerated to traditional approval following a determination that a confirmatory...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Considerations in Demonstrating Interchangeability With a R...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Circumstances That Constitute Delaying, Denying, Limiting, ...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Human User Safety in New and Abbreviated New Animal Drug Ap...[ Price : $8.95]
FDA announces a 7/22 public workshop on Best Practices for Meeting Management Under PDUFA VII.[ Price : $8.95]
Eli Lilly says it has submitted an NDA for weight loss therapy Mounjaro (tirzepatide) for treating moderate-to-severe obstructive ...[ Price : $8.95]
After receiving a 2019 complete response letter, Lexicon Pharmaceuticals resubmits its NDA for sotagliflozin oral tablets as an ad...