FDA rejection

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Biotech

Replimune's stock spikes 100% on FDA acceptance of resubmission

The FDA expects to make an approval decision on or before April 10, according to Replimune.
Gabrielle Masson Oct 20, 2025 5:33pm
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FDA snubs Fortress' Zydus-partnered Menkes disease candidate

Oct 1, 2025 12:00pm
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Capricor responds to cell therapy snub, disputes FDA’s concerns

Sep 9, 2025 11:44am
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Favicon Fierce Pharma

FDA's response letter salvo sheds light on drug refusal process

Jul 11, 2025 10:15am
Warning Letter FDA Warning Letter FDA

FDA chides Applied Therapeutics' trial conduct in warning letter

Dec 4, 2024 11:21am
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Lykos caps off chaotic week by cutting 75% of staff

Aug 15, 2024 3:59pm