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FDA turns down 'national priority' drug from Disc Medicine
One of the beneficiaries of the FDA's national priority vouchers, Disc Medicine, has had its marketing application turned down by the regulator.
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Report says Jim O'Neill's time at HHS is nearing its end
HHS Deputy Secretary Jim O'Neill – who is also head of the CDC – is said to be on the way out after a reshuffle of department leadership by RFK Jr.
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PTC pulls file for Duchenne therapy on FDA feedback
PTC Therapeutics has abandoned its latest attempt to secure FDA approval for Duchenne muscular dystrophy treatment Translarna.
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FDA says comparator dose scuppered Moderna's flu jab filing
The FDA has defended its decision to issue a refusal-to-file (RTF) letter for Moderna's new mRNA-based influenza vaccine.
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Moderna cries foul as FDA blocks filing of mRNA flu shot
The FDA won't accept Moderna's filing for an mRNA-based flu vaccine, in the latest signal of the changing regulatory climate for vaccines in the US.
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