FDA clears a Xironetic 510(k) for its IntraOpVSP augmented reality (AR) visualization software for use in complex surgeries.
Protalix BioTherapeutics and Chiesi Global Rare Diseases resubmit a BLA for PRX102 (pegunigalsidase alfa) for treating adult patients with Fabry disea...
Roche says results from two Phase 3 studies evaluating Alzheimers therapy gantenerumab were not statistically significant in slowing clinical decline....
Federal Register notice: FDA makes available a final guidance entitled Referencing the Definition of a Device in the Federal Food, Drug, and Cosmetic ...
Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Mercks Prevymis (letermovir) intravenous s...
Federal Register notice: FDA makes available a draft guidance entitled Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lin...
Satsuma Pharmaceuticals says topline results from the STS101 SUMMIT Phase 3 efficacy trial showed numerical differences in favor of its migraine drug ...
FDA grants ImmunoGen an accelerated approval for Elahere (mirvetuximab soravtansine-gynx) for treating certain adult patients with folate receptor alp...
