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- UniQure to file gene therapy for approval, reflecting major shifts at FDAThe decision marks another regulatory U-turn following the exits of Marty Makary and Vinay Prasad, suggesting to some analysts that current FDA leadership may be more flexible in certain cases.BioPharma Dive · 1mo ago↗ source
- STAT+: Advocacy groups petition FDA to withdraw approval of ‘unsafe’ use of antibiotics given to livestockMore than 60 organizations are urging the FDA to withdraw approval for what they called the “unsafe” use of antibiotics for preventing disease in food-producing livestock.STAT · 1mo ago↗ source
- Jazz zeroes in on next-gen T cell engagers with AbCellera dealThe potentially $4 billion collaboration is the latest example of drugmakers working to broaden the use of T cell engagers, which, so far, have had limited success outside of certain blood cancers.