FDA red and green lights: July 2025
Approvals come for Regeneron and Dizal, but Roche and Replimune see knockbacks.
Columvi avoids its worst-case scenario
Roche’s drug is knocked back in second-line lymphoma, but keeps its third-line nod.
Pivotal T-cell engager readouts approach
Data on J&J’s Tecvayli and Pfizer’s Elrexfio in relapsed multiple myeloma are due soon.
Licensing analysis: big deals bolster biotech
PD-(L)1 x VEGF bispecifics prove a big draw.
Regeneron enters the T-cell engager arena
Lynozyfic could have an edge over rival BCMA-targeting bispecifics.
EHA 2025 – J&J claims an extramedullary edge
The company sees an improvement with a Tecvayli/Talvey combo vs either monotherapy.
Akeso looks early in small-cell lung cancer
A new phase 3 could see ivonescimab challenge AstraZeneca’s Imfinzi in limited-stage disease.
ASCO 2025 – J&J challenges its own multiple myeloma T-cell engagers
Meanwhile, Ichnos Glenmark takes a different trispecific multiple myeloma approach.
