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FDA green and red lights: June 2024

Merck and Daiichi’s first ADC attempt is knocked back, while Geron gets its inaugural approval.

Sutro reads the farletuzumab tea leaves

Farletuzumab ecteribulin follows its parent MAb with a setback, spelling possible bad news for Sutro.

Regeneron gets a European reprieve

The EU recommendation for odronextamab comes after a US rejection in March.

Bicara chases Merus

But ficerafusp is limited to HPV-negative disease, and petosemtamab’s safety looks better.

Merck’s big ADC deal takes a blow

A complete response letter for Merck & Co and Daiichi’s patritumab deruxtecan might not be fatal, but it’s certainly embarrassing.

IO Biotech looks for an interim injection

The group plays down upcoming interim analysis, but still hopes for accelerated approval.

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