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Gene Therapy Approvals By US FDA Could Double In 2020

 
• By Bridget Silverman

CBER is starting the year with four novel gene and cell therapy applications under review and rolling submissions underway for more.

The number of gene therapies approved by the US Food and Drug Administration could double in 2020, thanks to surge in biologics license applications in the waning days of 2019. Four new gene therapies are now under review, and rolling submissions are underway or imminent for at least two more.

Despite longstanding hype about the potential of gene therapy, only a few have made it to FDA approval: Spark...

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