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U.S. Urges High Court Rejection of Compounding Case

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The U.S. government urges the Supreme Court to reject an appeal by a Texas compounding pharmacy in a closely watched case over whe...

Outlook Wins FDA Appeal After 3 Complete Responses

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Outlook Therapeutics wins an appeal with FDA over its BLA for ONS-5010/Lytenava (bevacizumab-vikg), clearing a potential path towa...

Intas Pharma Facility in India Hit With Form-483

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FDA investigators cite major quality control and data integrity concerns at an Indian manufacturing facility operated by Intas Pha...

Dyne Files BLA for Duchenne Muscular Dystrophy Therapy

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Dyne Therapeutics submits a BLA that seeks accelerated approval for its experimental Duchenne muscular dystrophy therapy z-rostudi...

Dont Expect a New FDA Commissioner Soon: Grossman Column

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FDA Matters founder Steven Grossman explains why he thinks it will take the Trump administration at least until the end of the yea...

Senator Concerned About Cybersecurity and Chinese Devices

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Senator Tom Cotton (R-AR) urges FDA and government cybersecurity officials to review Chinese-made medical devices cleared before u...

Biogen, Denali Halt Development of Parkinsons Drug in Idiopathic Disease

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Biogen and Denali Therapeutics limit the development of their experimental Parkinsons disease drug BIIB122 after the therapy faile...

FDA OKs Datroway for Triple-Negative Breast Cancer

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FDA approves Daiichi Sankyos Datroway (datopotamab deruxtecan-dlnk) for adults with unresectable or metastatic triple-negative bre...

Chronic Hepatitis Delta Virus Infection Treatment Approved

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FDA has approved Gilead Sciences Hepcludex (bulevirtide-gmod) for treating chronic hepatitis delta virus (HDV) infection, marking ...

Early Alert on Abiomed Heart Pump Controller Software Problem

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FDA issues an early alert about a potentially high-risk software problem involving certain heart pump controllers manufactured by ...