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Latest From Zogenix, Inc.
UCB Bullish On Bimzelx Despite Sluggish Start
While sales for the dual interleukin-17A and IL-17F inhibitor only reached €35m last year, UCB immunology chief Emmanuel Caeymaex is confident that figure will leap over the €200m barrier in 2023, if US approval for Bimzelx for psoriasis comes in the next quarter.
US FDA Advisory Committee ‘Update’ May Result In More Meetings – And More Re-Reviews
Commissioner Robert Califf’s comments offer further context for FDA’s unprecedented decision to reconvene an advisory committee for a second review of Amylyx’ AMX0035 for ALS.
What Might FDA Do Post Roe? Eliminate Mifepristone REMS
Attorneys say the biggest step FDA could take to expand access to medication abortion would be to eliminate REMS requirement for mifepristone. Timeline notes steps Biden administration and Congress have taken since the Supreme Court’s ruling overturning the right to an abortion.
Keeping Track: GSK’s Priorix Makes Three Novel US FDA CBER Approvals In 2022; Two CV Drugs Among Recent NDAs
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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