FDA says a new open-access dataset on gait patterns in patients with Parkinsons disease may lead to novel medical devices.
Three stakeholders tell FDA they oppose the idea of the agency developing product-specific guidances to promote biosimilar development.
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.
