EMA CHMP recommends marketing authorisation for Novartis’ PNH treatment
This endorsement is a significant step towards the availability of Fabhalta for PNH patients in Europe. The positive opinion is based on data from two Phase III clinical
GSK has received the US Food and Drug Administration's (FDA) acceptance for its supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) along with standard-of-care chemotherapy (carboplatin and paclitaxel).