FDA releases a guidance entitled Laboratory Developed Tests: Small Entity Compliance Guide.
FDA approves an Endotronix PMA for its Cordella Pulmonary Artery Sensor System for treating New York Heart Failure Class III heart failure patients.
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 ...
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...
Zoll Medical recalls (Class 1) its Zoll 731 Ventilators and their operator and quick reference guides.
Federal Register notice: FDA makes available a draft guidance entitled Considerations in Demonstrating Interchangeability With a Reference Product: Up...
