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:
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