FDA approves Gilead’s Vemlidy sNDA for paediatric HBV patients
This sNDA extends the indication of Vemlidy, a once a day 25mg tablet for usage in children aged six years and above weighing a minimum of 25kg with
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).