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FDA denies a 4/2023 petition that called on the agency to withdraw approval for Harmony Biosciences Wakix (pitolisant) and take ot...[ Price : $8.95]
After receiving a 2019 complete response letter, Lexicon Pharmaceuticals resubmits its NDA for sotagliflozin oral tablets as an ad...[ Price : $8.95]
CBER director Peter Marks again overrides his Centers review teams in approving a supplemental BLA that expands the approval and c...[ Price : $8.95]
Zoll Medical recalls (Class 1) its Zoll 731 Ventilators and their operator and quick reference guides.[ 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Federal Register notice: FDA makes available a draft guidance entitled Considerations in Demonstrating Interchangeability With a R...[ Price : $8.95]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.