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- With new data, Regenxbio to seek FDA approval of Duchenne gene therapyThough two serious side effects muddied the results, CEO Curran Simpson expressed optimism about a clearance and claimed FDA leadership will have a “mandate on rare disease flexibility.”BioPharma Dive · 3mo ago↗ source
- FDA’s leadership void leaves biotech with renewed ‘uncertainty’Marty Makary's resignation leaves the agency with temporary directors in three top positions, and a number of newly instituted policies with an unclear future.BioPharma Dive · 3mo ago↗ source
- Lilly data point to ‘maintenance’ strategies for GLP-1 weight lossA pair of trial results published in medical journals suggest switching from high-dose injectables to lower doses or pills could help people with obesity keep their weight down over the long term.