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Zogenix, Inc.

https://www.zogenix.com/

Latest From Zogenix, Inc.

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.

Advisory Committees Review Pathway

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.

FDA Drug Safety

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

US FDA Performance Tracker Approvals

England Okays Funding For Revestive, Jyseleca & Fintepla

England’s health technology appraisal body NICE has recommended Galapagos’ Jyseleca for ulcerative colitis, Takeda’s Revestive for short bowel syndrome and Zogenix’s Fintepla for seizures associated with Dravet syndrome.

Europe United Kingdom
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Other Names / Subsidiaries
    • Brabant Pharma, Modis Therapeutics, Inc. Zogenix International, Ltd. Zogenix Europe Limited
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