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FDA

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Biotech

Krystal discontinues melanoma study after FDA's Replimune rebuff

The FDA’s rebuff of Replimune’s melanoma candidate has rippled across the industry, prompting Krystal Biotech to shutter a clinical trial.
Gabrielle Masson Aug 21, 2025 10:50am
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FDA aims for September approval decision for Stealth's drug

Aug 21, 2025 10:15am
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After 'complete standstill,' biotech market reaches new normal

Aug 20, 2025 11:04am
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FDA clears Signos' over-the-counter, CGM-powered weight loss app

Aug 20, 2025 10:44am
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Rocket's gene therapy free from FDA hold

Aug 20, 2025 10:40am
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FDA snubs PTC's Friedreich's ataxia hopeful with CRL

Aug 19, 2025 10:55am

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