CDRH issues an Early Alert after becoming aware that GE HealthCare sent a letter alerting affected customers of updated use instructions for Portrait ...
Scholar Rock says it has made further regulatory progress for apitegromab, its investigational treatment for spinal muscular atrophy.
House Select Committee on China chairman John Moolenaar (R-MI) and Rep. Ben Cline (R-VA) are urging FDA intensify safeguards on clinical trial data ge...
CBER updates its standard operating procedures for resolving scientific/procedural disputes between sponsors and the Center, establishing revised proc...
FDA warns Gilbert, AZ-based Suretec Innovations about CGMP and drug listing violations in its manufacturing of finished drugs.
FDA issues a complete response letter to Xspray Pharmas NDA for Dasynoc, raising issues about a third-party manufacturer.
FDA grants Ultragenyx Pharmaceutical accelerated approval for its Genglycos (pariglasgene brecaparvovec-opnr) for adults and children eight years and ...
FDA warns Dayton, NJ-based Safrel Pharmaceuticals about CGMP violations in its manufacturing of finished drugs.
