Last year’s new drug approvals by FDA reflect the continued focus on best-in-class drug development

Half of FDA approvals are sponsored by biotechs; almost all are marketing in the U.S. themselves

After starting the month with two approvals, FDA’s remaining decisions include Gilead’s seladelpar, Regeneron’s BCMAxCD3 bispecific 

Plus: Galapagos-Adaptimmune enter TCR T cell deal, and digital therapeutics pioneer Akili opts for merger

Disappointing results for Immunocore’s PRAME-targeted TCR bispecific at ESMO sink shares

Zurich start-up raises $76M to develop bispecifics against MHC-displayed cancer targets

Plus Rowe new CSO at Cystic Fibrosis Foundation and updates from Immunovant, Senda, F2G and more

Kimmtrak authorization brings the first uveal melanoma therapy and a new immuno-oncology modality to market

And further builds confidence in TCR bispecifics for solid tumors

Adaptimmune’s initial pivotal readout for its MAGEA4-targeted TCR cell therapy adds to a trickle of positive data for cell therapies in solid tumors, where immunosuppressive