Bayer's Hyrnuo Enters First-Line Rivalry & FDA Gets Permanent Center Chiefs

Bayer's Hyrnuo (sevabertinib) gains first-line accelerated approval in HER2-mutant lung cancer, joining an established rival. Permanent FDA center leaders follow repeated turnover, while Structure's experimental obesity pill aleniglipron adds 72-week follow-up without a concurrent placebo. Kura, EMD Serono and Encoded back new development efforts; Tyra reports early bladder cancer responses, Evommune changes its eczema program, and Beeline advances lupus studies. BioMarin's Voxzogo (vosoritide) filing targets hypochondroplasia, and Nanoscope reports application acceptance for severe retinitis pigmentosa.Alex Mercer and Maya Patel host the Daily Roundup for September 9. Get the daily rundown in your inbox — subscribe at thepharmacloseout.com.