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Chronic Fatigue Syndrome Drug Development Efforts Get A Boost From FDA

 
• By Sue Sutter

Agency is undertaking a series of activities with patients, advocacy groups and other stakeholders aimed at spurring development of new treatments. Hemispherx is hoping its investigational drug Ampligen, currently under FDA review, will become an early beneficiary of new statutory provisions on expedited approval.

FDA has embarked on a drug development initiative for chronic fatigue syndrome and myalgic encephalomyelitis at the same time it is considering whether Hemispherx Biopharma Inc.’s Ampligen should be the first drug approved for CFS.

The agency is planning a series of activities with patients, advocacy groups and other stakeholders focused on development of drugs...

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More from United States

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• By Derrick Gingery

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More from North America

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
• By Sarah Karlin-Smith and Derrick Gingery

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

PCMA, CVS, Cigna File Lawsuits Over ‘Dangerous’ Arkansas PBM Law

 
• By Tim Casey

The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.