Stealth BioTherapeutics

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Biotech

FDA denies request to reconsider Stealth's ultrarare disease med

The biotech says it's "evaluating all options" after the FDA directed the biotech to resubmit a new drug application for its rare disease candidate.

Gabrielle Masson Aug 8, 2025 1:58pm

rare diseases

Stealth CEO questions FDA rejection of rare disease drug

May 29, 2025 2:27pm

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Stealth hit by FDA rejection to twice-delayed filing

May 29, 2025 7:46am

red tape delay stop error tie down stall

FDA misses PDUFA date for Stealth’s ultra-rare disease candidate

Apr 30, 2025 9:00am

FDA stop sign

FDA delays decision on Stealth's ultrarare disease med

Jan 23, 2025 9:45am

FDA Adcomm

After agony, FDA adcomm favors Stealth's ultra-rare disease drug

Oct 10, 2024 6:20pm