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- Novartis and Bristol Myers pause autoimmune CAR-T trials after serious safety eventsNovartis and Bristol Myers Squibb announced the suspension of several autoimmune CAR‑T studies after encountering serious safety problems. In Novartis' trials, three participants died from a severe…
- FDA CBER director overrides review team to grant accelerated approval for Replimune's melanoma therapy TudriqevA senior official at the FDA's Center for Biologics Evaluation and Research stepped in to reverse a prior rejection by the agency's review panel. The director of the office of clinical evaluation a…