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- Acting FDA commissioner touts strong interest in early-stage trial pilotActing US Food and Drug Administration (FDA) Commissioner Kyle Diamantas said there is significant public interest in its recently announced Expedited Investigational New Drug (IND) pilot at the Fr…raps · 23h ago↗ source
- Develop regulatory intelligence system before legal deadlines, experts sayBARCELONA – Experts noted that companies shouldn’t wait until a law is enacted to begin developing regulatory intelligence. Instead, they recommended that regulatory professionals engage with key s…raps · 23h ago↗ source
- FDA Approves First Factor Xla Inhibitor to Help Prevent Stroke in Certain Adults at High RiskFDA today approved Sunharbo (asundexian) 50 mg tablets, the first factor XIa (FXIa) inhibitor for use in combination with antiplatelet therapy to reduce the risk of stroke in adults following a rec…