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Federal Register notice: FDA makes available a draft guidance entitled Considerations in Demonstrating Interchangeability With a Reference Product: Up...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...
After receiving a 2019 complete response letter, Lexicon Pharmaceuticals resubmits its NDA for sotagliflozin oral tablets as an adjunct to insulin the...
CBER director Peter Marks again overrides his Centers review teams in approving a supplemental BLA that expands the approval and converts to full appr...
