Federal Register notice: FDA announces a publication containing modifications it is making to the list of standards FDA recognizes for use in premarke...
Federal Register notice: FDA determines that Janssen Pharmaceuticals Invega (paliperidone) extended-release tablet was not withdrawn from sale due to ...
FDA converts Janssens Sirturo (bedaquiline) from accelerated to traditional approval following a determination that a confirmatory trial verified clin...
Federal Register notice: FDA makes available a draft guidance entitled Considerations in Demonstrating Interchangeability With a Reference Product: Up...
Federal Register notice: FDA makes available a final guidance entitled Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug o...
Federal Register notice: FDA makes available a final guidance entitled Human User Safety in New and Abbreviated New Animal Drug Applications.
FDA announces a 7/22 public workshop on Best Practices for Meeting Management Under PDUFA VII.
Eli Lilly says it has submitted an NDA for weight loss therapy Mounjaro (tirzepatide) for treating moderate-to-severe obstructive sleep apnea and obes...
