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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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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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CSL sinks to nine-year low on revenue warning, $5B write-down

CSL sinks to nine-year low on revenue warning, $5B write-down

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CSL’s stock hit its lowest price since early 2017 on Monday after it lowered its full-year revenue guidance by about 4% and said it would have to take a new $5 billion impairment charge.

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Precision in motion: Decoding the critical operations behind the logistics of next-generation cell and gene therapies

The future of medicine is here. See how specialized logistics are saving lives with next-gen cell and gene therapies.

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The future of medicine is here. See how specialized logistics are saving lives with next-gen cell and gene therapies.

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