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FDA names CDRH deputy director Michelle Tarver as the new Center director, replacing retiring head Jeff Shuren, who hand-picked hi...[ Price : $8.95]
FDA says a new open-access dataset on gait patterns in patients with Parkinsons disease may lead to novel medical devices.[ Price : $8.95]
Three stakeholders tell FDA they oppose the idea of the agency developing product-specific guidances to promote biosimilar develop...[ Price : $8.95]
FDA posts an executive summary and questions for discussion at a scheduled 11/20-21 meeting of its Digital Health Advisory Committ...[ Price : $8.95]
FDA accepts for review a Lenz Therapeutics NDA for LNZ100 (aceclidine), an eyedrop medication for treating presbyopia.[ Price : $8.95]
Novo Nordisk says it will submit a NDA supplement seeking an expanded label for its diabetes drug Rybelsus (semaglutide) based on ...[ Price : $8.95]
Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Pfizers Vyndaqel (tafa...[ Price : $8.95]
FDA accepts for review an Elevar Therapeutics NDA resubmission for its investigational drug rivoceranib, in combination with camre...