[ Price : $8.95]
FDA issues a final guidance describing how it evaluates therapeutic equivalence among prescription drug products and assigns thera...[ Price : $8.95]
CDRH issues an Early Alert after becoming aware that GE HealthCare sent a letter alerting affected customers of updated use instru...[ Price : $8.95]
Boston Scientific recalls its ENROUTE Transcarotid Neuroprotection System Plus, a single-use percutaneous catheter kit used during...[ Price : $8.95]
FDA warns Gilbert, AZ-based Suretec Innovations about CGMP and drug listing violations in its manufacturing of finished drugs.[ Price : $8.95]
FDA warns Dayton, NJ-based Safrel Pharmaceuticals about CGMP violations in its manufacturing of finished drugs.[ Price : $8.95]
FDA issues a complete response letter to Xspray Pharmas NDA for Dasynoc, raising issues about a third-party manufacturer.[ Price : $8.95]
FDA grants Ultragenyx Pharmaceutical accelerated approval for its Genglycos (pariglasgene brecaparvovec-opnr) for adults and child...[ Price : $8.95]
Senate confirmation of FDA commissioner nominee Heidi Overton appears to be getting some resistance and a quick Senate confirmatio...