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- FDA Approves First Single-Dose Generic Treatment for InfluenzaThe U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in…fda press · 1mo ago↗ source
- 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
- 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.