FDA green and red lights: June 2024
Merck and Daiichi’s first ADC attempt is knocked back, while Geron gets its inaugural approval.
Merck and Daiichi’s first ADC attempt is knocked back, while Geron gets its inaugural approval.
Farletuzumab ecteribulin follows its parent MAb with a setback, spelling possible bad news for Sutro.
The EU recommendation for odronextamab comes after a US rejection in March.
But ficerafusp is limited to HPV-negative disease, and petosemtamab’s safety looks better.
Predictably Tacti-003 fails, but funding is secured – from investors, not a partner.
Earnings season begins again, while big readouts loom for ALX and Fibrogen.
A complete response letter for Merck & Co and Daiichi’s patritumab deruxtecan might not be fatal, but it’s certainly embarrassing.
The ROR1 data are sketchy, and lung toxicity clouds prospects.