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).
The FTC files an amicus brief with the Delaware federal court in the case of Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals, taking issue with a J...
