FDA approves a Genentech supplemental BLA for Xolair (omalizumab) for the add-on maintenance treatment of nasal polyps in adult patients having an ina...
Federal Register notice: FDA makes available a draft guidance entitled Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents:...
President Trumps chief of staff Mark Meadows summons FDA commissioner Stephen Hahn to the White House 12/1 to learn why the agency has not approved or...
FDA recognizes A2LA to assess testing laboratories for the Accreditation Scheme for Conformity Assessment pilot program.
Minerva Neurosciences says it believes it can address negative FDA comments about two roluperidone studies through published regulatory guidance and p...
FDA releases its latest batch of Warning Letters that include ForYou Inc. and Industry Lab Diagnostic Partners.
Federal Register notice: FDA extends the comment period for a 10/13 notice announcing a public meeting and requesting comments on a potential revised ...
Federal Register notice: FDA makes available a final guidance for industry #242 entitled In-Use Stability Studies and Associated Labeling Statements f...