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FDA priority review

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Bavarian Nordic's $160M PRV price reflects new realities

The value of PRVs appears to be on the rise as concerns mount over declining supplies following the sunset of the rare pediatric disease PRV program.
Angus Liu Jun 18, 2025 11:47am
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FDA 'on track' to meet all PDUFA dates, Marty Makary says

Jun 18, 2025 4:00am
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FDA debuts priority review voucher with 2-month timeline goal

Jun 17, 2025 11:59am
rare diseases

Stealth CEO questions FDA rejection of rare disease drug

May 29, 2025 2:27pm
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Vertex meets own cystic fibrosis record with next-gen treatment

Feb 5, 2024 7:50pm
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FDA gives Madrigal's NASH drug priority review, no AdComm

Sep 13, 2023 10:50am

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