The House Energy and Commerce Committee seeks additional inspection records from FDA after its analysis of the foreign drug inspection program found t...
FDA denies a 4/2023 petition that called on the agency to withdraw approval for Harmony Biosciences Wakix (pitolisant) and take other actions against ...
Federal Register notice: FDA makes available a draft guidance entitled Considerations in Demonstrating Interchangeability With a Reference Product: Up...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...
