US FDA grants orphan drug status for Rznomics’ HCC treatment
This designation could lead to seven years of marketing exclusivity on receipt of an approval, as well as exemption from user fees and eligibility for tax credits. Furthermore,
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 treatment is intended for usage in adults with priorly untreated la/mUC. This development marks a significant step towards potentially offering an alternative to the current standard platinum-containing