Complete Response Letter

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

The FDA's response letter salvo offers an in-depth view into the high-stakes discussions that decide whether a medicine will ever make it to market.
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FDA rejects Capricor’s DMD cell therapy, asks for more data

Jul 11, 2025 9:18am
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FDA shares more than 200 CRLs for now-approved drugs

Jul 10, 2025 10:54am
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
Delayed on hold

Vanda sues FDA over months-long hearing delay

Apr 23, 2025 10:33am