FDA
Biotech

Merck and Daiichi pull lung cancer filing after FDA pushback

Daiichi and Merck withdrew an ADC filing after the FDA said they lacked the data for accelerated approval in a lung cancer population.
Nick Paul Taylor Sep 28, 2026 4:30am
New approach methodologies in safety and toxicology testing Why proving repeatability is the next hurdle for widespread adop

Why proving repeatability is the next hurdle for widespread adoption

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Make a delay and accumulation of outstanding tasks Full stop

Roche drops obesity antibody after flunked interim analysis

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On target clinical trial success bullseye score

Mirum posts ph. 3 hepatitis win for challenger to Gilead, Vir

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money flying in

Scynexis bags $214M BARDA contract for antifungal development

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Deal

Tolerance continues thymus-focused deals with $560M Tanabe pact

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Adicet Bio CAR-T sparks lupus remissions in early-stage trial

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Fierce Pharma

Lundbeck relocating US headquarters to Boston in innovation move

Sep 25, 2026 10:41am