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- How Kyverna rode CAR T’s autoimmune wave to the FDA’s doorPoised to become the first company to achieve a regulatory filing for a cell therapy in autoimmune disease, Kyverna Therapeutics is building a pipeline-in-a-product to change the treatment paradigm.BioSpace · 10d ago↗ source
- Early Alert: Intravascular Administration Set Issue from BaxterBaxter administration sets may have air bubbles in the drip chamber and tubing, which may result in air being delivered through the IV line to the patient.fda medwatch · 10d ago↗ source
- Recon: BMS to construct AI supercomputer with Nividia; Tempus to acquire cancer diagnostic maker Personalis for $1.5BWelcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.