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Keeping Track: Two Goal Date Extensions, Another Herceptin Biosimilar Approval, And A BLA Withdrawal

 
• By Michael Cipriano and Bridget Silverman

The latest drug development news and highlights from our US FDA Performance Tracker.

Keeping Track Feature image

A US FDA green light for Karyopharm Therapeutics Inc.'s selinexor seemed highly unlikely following a February advisory committee meeting, but the company may have a reason to hope for approval, as the agency delayed the user fee goal date by three months following the submission of additional data.

Also landing a three-month user fee extension was Bavarian Nordic AS’s smallpox vaccine MVA-BN, for which the sponsor similarly...

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