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Human Drugs

FDA, FTC Biosimilar Workshop Summary Out

FDA releases a summary of a 2020 workshop held with the Federal Trade Commission on a competitive marketplace for biosimilars.

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FDA General

Califf Expands on ORA Restructuring

FDA commissioner Robert Califf updates several activities that are part of his vision for restructuring the Office of Regulatory Affairs and the agenc...

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Human Drugs

Group Petitions for More Trial Reporting Enforcement

Universities Allied for Essential Medicines is calling on FDA to step up enforcement of the clinical trial reporting requirements in the 2007 FDA Amen...

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Human Drugs

Gasc Industrial Warned on GMPs

FDA issues Gasc Industrial Corp. in Gurabo, Puerto Rico, a Warning Letter after inspecting its manufacturing facility and citing significant GMP viola...

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Human Drugs

Merck Discontinues Keytruda Prostate Cancer Trial

Merck says it is discontinuing the Phase 3 KEYNOTE-641 trial evaluating Keytruda (pembrolizumab) in combination with enzalutamide and androgen depriva...

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Biologics

FDA Panel Backs Pfizer RSV Vaccine

FDAs Vaccines and Related Biological Products Advisory Committee votes to recommend approval of Pfizers respiratory syncytial virus bivalent vaccine R...

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Human Drugs

FDA Seeks Comments on AI Areas in Drug Manufacturing

FDA seeks comments on a just-released discussion paper on artificial intelligence areas for use in drug manufacturing and policy development associate...

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Federal Register

FDA Denies Hearing Request on Fleming

Federal Register notice: FDA denies a hearing request from Richard M. Fleming seeking to terminate his 2018 debarment order.

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Human Drugs

Reata Pharmaceuticals Friedreichs Ataxia Drug Approved

FDA approves a Reata Pharmaceuticals NDA for Skyclarys (omaveloxolone) as the first treatment for Friedreichs ataxia, a rare degenerative disease that...

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Human Drugs

CDER Neuroscience Director Dunn Leaving Agency

CDER Office of Neuroscience director Billy Dunn, a top figure in FDAs controversial approval of Biogens Alzheimers drug Aduhelm, announces his retirem...