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FDA reportedly shelves speedy drug-review voucher program

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A Reuters report dated November 12 says the FDA has effectively shelved the Commissioner’s National Priority Voucher (CNPV) pilot, launched in 2025 under former commissioner Marty Makary to shorten some drug reviews to one or two months. No new vouchers have reportedly been issued since Makary left in May. The political-appointee executive council overseeing the initiative has gone dormant, and sources say new applications are not progressing even though submissions remain open. The pilot issued vouchers to 22 drugs; 12 have since been approved. Reuters reported that, for several, the program shortened approval timelines by eight months or more. Career FDA staff are reportedly handling timelines for the remaining participants. It is not formally confirmed as terminated: HHS says the pilot is ongoing while the FDA reviews public feedback and considers refinements. So “dead” is a fair description of its apparent current status, but the agency disputes that it has ended. Sources...

Study finds drug ads can sway AI treatment recommendations

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Alterra Labs raises $12.5 million to test and improve healthcare AI

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Google Cloud launches Gemini for healthcare

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Beeline reports positive Phase 2 results for lupus drug afimetoran

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Neurosterix raises $105 million to advance schizophrenia drug

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Blackstone to fund up to $1.5 billion of Pfizer’s berobenatide development

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Analysis: Raising German drug prices could raise costs on both sides

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VectorY raises $83.5 million to advance experimental neurodegenerative-disease therapies

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FDA approves Merck’s Abbisko-licensed drug for rare joint tumor

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Capricor and NextCure disclose layoffs amid FDA review and merger preparations

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FDA requires rare eye-condition warning on GLP-1 drug labels

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Flagship combines Valo and Montai

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