FDA

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Biotech

Analysts skeptical Applied can bring rare disease drug to market

Applied Therapeutics’ lack of progress on govorestat have led analysts to question whether the biotech will ever be able to get the drug to market.

James Waldron Nov 14, 2025 5:25am

Makary

FDA unveils new pathway to speed custom gene editing therapies

Nov 12, 2025 5:00pm

Richard Pazdur

Fierce Pharma

FDA names oncology vet Pazdur as new CDER director

Nov 11, 2025 5:18pm

FDA stop sign

FDA puts Tenaya heart disease gene therapy trial on hold

Nov 10, 2025 5:16am

Martin Makary FDA Senate HELP confirmation

FDA reveals 2nd round of 'national priority' voucher winners

Nov 6, 2025 3:12pm

Graphic image of a red thumbs down against a blue background

FDA rejects Biohaven approval request, triggering cost cutting

Nov 5, 2025 4:02am