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Keeping Track: An Approval For Ajovy, A CRL For Ruconest, And Some Submissions from J&J

 
• By Michael Cipriano, Brenda Sandburg, and Bridget Silverman

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

Keeping Track Feature image

The US FDA's 2018 novel drug approval count continues to rise, with Teva Pharmaceutical Industries Ltd.'s preventative migraine treatment Ajovy (fremanezumab) joining the party as No. 37.

Pharming Group NV's hereditary angioedema (HAE) treatment Ruconest (C1 Esterase Inhibitor [recombinant]) didn't fare as well, however. The company failed to pick up a supplemental indication for prophylactic use.

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