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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 to treat the symptoms of CFS/ME

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