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accelerated approval

Pfizer
Pharma

ASCO: Pfizer's Braftovi combo slashes death risk in rare cancer

Pfizer's Braftovi, combined with Eli Lilly's Erbitux and chemo, won an accelerated approval last year through the FDA's Project FrontRunner.
Zoey Becker May 30, 2025 8:00am
rare diseases
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Stealth CEO questions FDA rejection of rare disease drug

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AbbVie

AbbVie's ADC bet pays off with FDA nod for Emrelis

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Marks

CBER chief Peter Marks resigns from FDA

Mar 31, 2025 10:50am
FDA

OIG says FDA accelerated approval program needs adjustments

Jan 16, 2025 3:45pm
FDA

FDA looks to clarify follow-up testing mandate for speedy nods

Jan 6, 2025 3:36pm

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