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21% of FDA Staff Gone: Analysis

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An in-depth ProPublica report details the effects of massive staffing cuts at FDA and other HHS agencies that experts say threaten...

14 States Join Mifepristone Petition to FDA

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14 states join a petition submitted by four other states calling on FDA to eliminate the mifepristone REMS requirements in their s...

FDA Orphan Status for Keros Duchenne Candidate

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FDA grants Keros Therapeutics an orphan drug designation for its investigational therapy KER-065 and its use in treating Duchenne ...

Workshop on Allergic Dermatitis Patch Test Alternatives

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FDA announces a 10/23 public workshop to discuss the regulatory status of, and potential alternatives to, patch tests used in diag...

Nucleus RadioPharma Names Former FDA Head as CEO

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Nucleus RadioPharma appoints former FDA commissioner Stephen Hahn (Trump Administration 2019-2021) as its chief executive officer.

FDA Rejects enVVeno Medical Venous Valve PMA

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FDA issues enVVeno Medical a not-approvable letter for its PMA on VenoValve, a surgical replacement venous valve designed to treat...

FDA Lifts Hold on Rockets Gene Therapy

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FDA lifts a clinical hold on Rocket Pharmaceuticals pivotal Phase 2 trial of RP-A501, an investigational gene therapy for Danon di...

Impact of FDA China Cell Rule Unclear: Experts

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Experts share varying opinions with Clinical Trials Arena on the impact of an FDA rule barring biotech companies from sending cell...

Stop Inaccurate Health Info: HHS Staff to RFK, Jr.

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Some 750 current and former HHSers call on secretary Robert F. Kennedy, Jr., to protect them and the rest of his staff from attack...

FDA Updates Breakthrough Device Statistics

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Updated medical device breakthrough device designation metrics show 1,176 approvals since 2015 and 160 marketing authorizations.