Federal Register notice: FDA makes available a draft guidance entitled Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lin...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...
Insulet issues a Medical Device Correction for the Omnipod 5 Automated Insulin Delivery System because of an overheating issue with the Omnipod 5 Cont...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Mercks Prevymis (letermovir).
Federal Register notice: FDA sends to OMB an information collection extension entitled Data to Support Social and Behavioral Research as Used by the F...
Federal Register notice: FDA extends by two months the comment period on two proposed rules that appeared in the 9/28 Federal Register.
GSK says it has complied with an FDA request to restrict the second-line maintenance indication for cancer drug Zejula (niraparib).
