Pfizer gets CRL on Epogen biosimilar from FDA
According to Pfizer, the letter is related to points made by the regulator in a February-issued warning letter after a routine inspection of the pharma’s McPherson facility in
The US Food and Drug Administration (FDA) has granted priority review to Roche’s supplemental biologics licence application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) to treat adults with primary membranous nephropathy (pMN).
The companies plan to initiate a Phase 2 open-label, randomized, non-comparative study to evaluate the safety, tolerability and efficacy of eFFECTOR’s investigational small molecule MNK1/2 inhibitor, eFT508, in