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- Novartis CAR-T trial deaths spark safety concerns for autoimmune applicationsNovartis disclosed that three participants in its CAR-T cell therapy trials for autoimmune disease have died. The company said the deaths were reported to health authorities and are under investiga…
- 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…