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FDA, FTC Biosimilar Workshop Summary Out

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

Califf Expands on ORA Restructuring

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

Group Petitions for More Trial Reporting Enforcement

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

Gasc Industrial Warned on GMPs

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

Merck Discontinues Keytruda Prostate Cancer Trial

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

FDA Panel Backs Pfizer RSV Vaccine

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FDAs Vaccines and Related Biological Products Advisory Committee votes to recommend approval of Pfizers respiratory syncytial viru...

FDA Seeks Comments on AI Areas in Drug Manufacturing

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

FDA Denies Hearing Request on Fleming

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

Reata Pharmaceuticals Friedreichs Ataxia Drug Approved

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

CDER Neuroscience Director Dunn Leaving Agency

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