FDA

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Biotech

Replimune’s stock spikes 100% on FDA acceptance of resubmission

The FDA expects to make an approval decision on or by April 10, according to Replimune.
Gabrielle Masson Oct 20, 2025 5:33pm
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Astellas turns down option to license Taysha gene therapy—again

Oct 17, 2025 10:50am
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Unpacking the FDA transparency push on CRLs

Oct 17, 2025 9:41am
cancelled flights

Kezar plans layoffs after FDA axes meeting to discuss next trial

Oct 17, 2025 8:55am
accelerated

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

Oct 17, 2025 8:30am
Lab mouse in a transparent glass tube

Former FDA deputy to guide Charles River animal testing strategy

Oct 15, 2025 10:00am