FDA green and red lights: June 2024
Merck and Daiichi’s first ADC attempt is knocked back, while Geron gets its inaugural approval.
Regeneron gets a European reprieve
The EU recommendation for odronextamab comes after a US rejection in March.
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.
Bristol overtakes Amgen in colorectal
Meanwhile, Bristol’s other competition in this disease looks set to come from China.
Toxicity hits BioNTech’s MediLink tie-up
A mysterious ASCO poster, patient deaths and now clinical hold; where next for BioNTech’s ADC deal?
Endometrial cancer becomes a three-horse race
Imfinzi scores an unexpected approval based on a post-hoc subgroup analysis.
FDA green and red lights: May 2024
Breyanzi and Imdelltra head up May’s approvals, while camrelizumab’s CRL is a lowlight.
Telix heads to the US, as RayzeBio runs into problems
Supply continues to cause headaches for radiopharmaceutical developers.
