Update for October 21, 2022
The FDA accepted the resubmitted BLA for BioMarin’s valoctocogene roxaparvovec, for the treatment of severe hemophilia A, and set a PDUFA date for 3/31/2023.
The FDA delayed the PDUFA date for Biogen’s tofersen, by three months to 4/25/2023, and requested new information
The FDA granted Fast Track status to Nanoscope’s MCO-010 for the treatment of retinitis pigmentosa
Pharming submitted an MAA for leniolisib for the treatment of activated phosphoinositide 3-kinase delta syndrome.
CHMP recommended approval of:
Comments are closed.
Stay informed, subscribe to the
Prescribe Right Pharmaceutical Pipeline Tracker
Latest Tweets from Prescribe Right