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Pipeline News and Updates
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Update for October 21, 2022

10/21/2022

 
Regulatory Update
 
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: 
  • Takeda’s dengue vaccine to prevent dengue fever
  • Maralixibat to treat cholestatic pruritus in patients with Alagille syndrome
  • Lutetium Lu 177 vipivotide tetraxeta to treat prostate cancer
  • Spesolimab to treat generalized pustular psoriasis

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