FDA red and green lights: April 2026
Full US approval of Gilead’s Tecartus was the only positive decision last month.
Replimune’s fight with the FDA deepens
The oncolytic virus vuso-vec is slapped with its second CRL.
The month ahead: April’s upcoming events
Replimune gets a second chance, while Sarclisa could go subcutaneous.
FDA red and green lights: July 2025
Approvals come for Regeneron and Dizal, but Roche and Replimune see knockbacks.
FDA rejects Replimune’s oncolytic virus
There are questions about vuso-vec’s supporting and confirmatory trials.
Ideaya eyes neoadjuvant uveal melanoma
But some phase 3 details are unconfirmed, and phase 2 data haven’t shed light on the biggest question.
Replimune goes pivotal in uveal melanoma
The group eyes a broader use than Immunocore’s Kimmtrak.
Replimune challenges Iovance
The company’s vuso-vec looks similar to Amtagvi, and could have safety and convenience advantages.
