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Unnamed pharma files citizen petition targeting FDA’s trove of rejection letters

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The FDA in July 2025 made publicly available over 200 complete response letters—an initiative that the investment community sees as “unanimously positive,” analysts told BioSpace.

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Makary’s reported FDA removal could be ‘broad positive’ for biopharma

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The widely covered impending ouster of FDA Commissioner Marty Makary not long after the exit of controversial biologics head Vinay Prasad highlights the severe turnover rates at the highest rungs of leadership at the health department.

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Partner’s Bizengri cleared by FDA for ultra-rare cancer days after winning priority voucher

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Partner Therapeutics announced last week that the FDA had granted Bizengri a Commissioner’s National Priority Voucher to accelerate drug review.

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European regulators greenlight Fractyl Health’s clinical test of GLP-1 gene therapy

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Drug developers are racing to make gene therapies that could replace chronic GLP-1 injections and pills with a one-and-done treatment. Now, a company based just outside of Boston is poised to become …

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