FDA posts an executive summary and questions for discussion at a scheduled 11/20-21 meeting of its Digital Health Advisory Committee to discuss total ...
FDA accepts for review a Lenz Therapeutics NDA for LNZ100 (aceclidine), an eyedrop medication for treating presbyopia.
Novo Nordisk says it will submit a NDA supplement seeking an expanded label for its diabetes drug Rybelsus (semaglutide) based on data from the SOUL c...
Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Pfizers Vyndaqel (tafamidis meglumine).
FDA accepts for review an Elevar Therapeutics NDA resubmission for its investigational drug rivoceranib, in combination with camrelizumab, as a first-...
FDA clears an iRhythm Technologies 510(k) related to prior design changes made to the Zio AT cardiac telemetry device.
A coalition of 18 attorneys general file a Fourth Circuit appellate brief in support of a lower court decision finding that North Carolina cannot impo...
House Energy and Commerce Committee republicans ask HHS inspector general Christi Grimm to assess the adequacy of FDAs oversight and support of its Of...
