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FDA priority review

rare diseases
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.
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FDA gives Madrigal's NASH drug priority review, no AdComm

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Pfizer's maternal RSV vaccine filing sets up AZ, Sanofi showdown

Feb 21, 2023 9:15am
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Pfizer's RSV vaccine rush gets FDA boost with priority review

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