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FDA green and red lights: April 2024

A tumour-agnostic label for Enhertu leads April’s US oncology approvals.

Calliditas puts a brave face on setanaxib failure

A phase 2 head and neck trial missed its primary endpoint, but the group is taking heart from survival data.

A new menin challenger

Hutchmed starts phase 1 with a project in a field where Syndax and Kura have so far been the main players.

Glycomimetics down and out on upro miss

The company’s long-delayed pivotal trial is hit by a stronger-than-expected placebo performance.

BridgeBio’s oncology spinout must stand out from the crowd

The new developer will focus on the crowded KRAS space and PI3Kα/AKT inhibition, which has been hit by toxicity issues.

A Calquence win seven years in the making

AstraZeneca celebrates success in the Echo trial in mantle cell lymphoma, but watch out for BeiGene.

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