The approval was based on data from the phase 3 PROpel trial.
A regulatory decision is expected on November 27, 2023.
Training should be provided to patients and caregivers on how to appropriately administer Udenyca via the prefilled autoinjector.
Fylnetra is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
Polivy plus R-CHP is approved for the first-line treatment of patients with DLBCL NOS or HGBL who have an IPI score of 2 or greater.
Omisirge is a nicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from cord blood.
InflaRx is working to increase the US supply of Gohibic (vilobelimab) as quickly as possible.
The FDA has granted accelerated approval to Padcev with Keytruda for locally advanced or metastatic urothelial cancer.
Erleada (apalutamide) is now available in a 240 mg tablet.
The conversion from accelerated approval to regular approval was based on data from the KEYNOTE-158 trial, the KEYNOTE-164 trial, and the KEYNOTE-051 trial.
