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Marty Makary

accelerated
Biotech

Regeneron, Sanofi receive 1- to 2-month priority review vouchers

The national priority vouchers position companies including Merck KGaA, Regeneron and Sanofi to complete the review process in one to two months.
Nick Paul Taylor Oct 17, 2025 8:30am
FDA
Favicon Fierce Pharma

Under Trump, FDA seeks to abandon expert reviews of new drugs

Sep 12, 2025 9:50am
Image of a neon sign with the word no lit up next to an unlit yes

FDA rejects another ultrarare disease prospect

Sep 8, 2025 10:59am
FDA

FDA plans real-time release of drug rejection letters

Sep 4, 2025 1:45pm
yellow road to bright light

FDA proposes new approval pathway for rare diseases

Sep 3, 2025 1:20pm
dominoes fall series fail

Krystal discontinues melanoma study after FDA's Replimune rebuff

Aug 21, 2025 10:50am

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