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accelerated approval
Biotech
Stealth CEO questions FDA rejection of rare disease drug
“We are kind of hanging on by our fingernails here to try to bring this drug to the patient community,” Stealth CEO Reenie McCarthy told Fierce Biotech.
Gabrielle Masson
May 29, 2025 2:27pm
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How Peter Marks plans to prevent '3 billion visits' to FDA
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FDA's Richard Pazdur explains confirmatory trial rejection, more
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