October 8, 2024 01:59 PM EDT

FDA again raises doubts on Stealth's ultra-rare disease drug ahead of adcomm

Zachary Brennan

Senior Editor

Data submitted to the FDA by Stealth BioTherapeutics for its ultra-rare disease drug likely aren’t sufficient for an approval or even an accelerated approval, agency …

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FDA again raises doubts on Stealth's ultra-rare disease drug ahead of adcomm

Zachary Brennan

Senior Editor

Sign up to read this article for free.

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FDA again rais­es doubts on Stealth's ul­tra-rare dis­ease drug ahead of ad­comm

Zachary Brennan

Senior Editor

Sign up to read this article for free.

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FDA again raises doubts on Stealth's ultra-rare disease drug ahead of adcomm

Despite mixed data in Alzheimer's agitation, Axsome will still seek FDA approval

Ideaya inks ADC deal with $75M upfront; Amylyx, Gubra to develop long-acting GLP-1

BioNTech settles with NIH, UPenn in Covid vaccine disputes and will pay royalties

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Califf, on his way out at FDA, predicts agency tug-of-war between Ramaswamy and RFK Jr.

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