FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA's union readies negotiations with HHS over some fired staff

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Sandoz sues Amgen over nine-year launch delay for Enbrel biosimilar

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Ironwood to look for alternative paths after FDA asks for another Phase 3

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Makary wants to replace animal testing with organoids. It may take a while

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Bristol Myers' immunotherapy combo nets approvals in colorectal and liver cancer

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CDMOs anticipate inspection bottlenecks after mass FDA firings

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FDA quietly begins reversing return-to-office mandate for some workers

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Biotech CEOs to Cassidy: We're already seeing the effects of FDA's staff cuts

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Firings of HHS' probationary workers can proceed, appeals court says

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Drug pricing watchdog ICER offers ways to increase obesity drug access

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House panel mulls ways to boost struggling US biosimilar market

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Could Kennedy's FDA cuts trigger an obscure clawback provision for industry user fees?

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Rare disease hub at CDER and CBER faces new reality with staff crunch

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‘This is self-inflicted’: Leerink’s David Risinger on the market shock and hits to biopharma

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RFK Jr. won’t testify before key Senate committee this week on HHS overhaul

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Trump administration leaves obesity coverage expansion out of new Medicare rule

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Marks was asked to provide non-existent vaccine risk data: WSJ

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Novavax’s held-up approval package may signal warning for Covid vaccine makers

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Kennedy team defends Marks firing, while 20% of staff cuts may be 'mistakes'

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Senate confirms Dr. Oz to lead Medicare agency amid HHS overhaul

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FDA approves Amgen's Uplizna in IgG4-related disease

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Trump has touted Right to Try as a lifesaver. Several government staff supporting it were just let go

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House and Senate committees call for briefings on health cuts from Kennedy

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FDA will consolidate to five 'shared services offices,' according to memo to Hill staffers

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