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- FDA’s push to publish complete response letters faces legal uncertainty and possible pauseThe FDA began releasing complete response letters (CRLs) to the public last year, a move promoted as increasing transparency for drug developers, investors, and patients. However, the policy has e…
- Kyverna Therapeutics aims to file first CAR-T cell therapy for autoimmune diseaseKyverna Therapeutics is preparing what could become the first regulatory filing for a CAR-T cell therapy targeting an autoimmune condition. The company has been developing its miv-cel construct in…