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FDA priority review

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Pharma

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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Favicon Fierce Biotech

FDA 'on track' to meet all PDUFA dates, Marty Makary says

Jun 18, 2025 4:00am
rare diseases
Favicon Fierce Biotech

Stealth CEO questions FDA rejection of rare disease drug

May 29, 2025 2:27pm
Redbrick building with Sarepta name and logo

Sarepta's Elevidys expansion bid gets fast review without adcomm

Feb 16, 2024 11:05am
Leqembi official photo

FDA gives Eisai's Leqembi July 6 priority review date

Mar 6, 2023 11:45am
Prevnar 13

FDA grants Pfizer's Prevnar 20 priority review for pediatric use

Jan 6, 2023 10:20am

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