Keeping Track: US FDA Receives Advanced Biologic BLAs From ImmunityBio, CSL; Nymox, Medac Stumble
The latest NDA and BLA submission news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Sanofi/Sobi’s efanesoctocog is in line for US FDA action three months after CSL/uniQure’s gene therapy user fee goal, while BioMarin’s Roctavian resubmission and Novo Nordisk’s concizumab are waiting in the wings.
Agency should require physician training, facility certification, and patient registry as a condition for approving BioMarin's and CSL Behring’s investigational gene therapies, the advocacy group says. It calls for treatment to be limited to the population studied with no-off label use.
Keeping Track: TGT’s Ukoniq Is Latest PI3K Inhibitor To Fall; GSK’s Daprodustat, Aeglea’s Pegzilarginase Headline Submissions
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker