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- Capricor, Replimune reviews signal FDA’s return to reliability but every application will stand aloneFollowing a tumultuous stretch under ex-Commissioner Marty Makary, current FDA leadership is working to restore reliability, integrity and transparency to the agency—but experts say that doesn’t ne…BioSpace · 29m ago↗ source
- US lawmakers push FDA to tighten rules on Chinese clinical data after three gene therapy deathsThree recent deaths in separate gene‑therapy trials in China have prompted two members of the U.S. House of Representatives to call on the FDA for new safeguards. Representatives John Moolenaar an…