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- Industry groups call for clearer FDA guidance on QRIs in expedited IND pilotPharmaceutical trade groups have voiced concerns about the FDA's proposed expedited IND pilot, which aims to speed entry of drug candidates into first‑in‑human studies. The groups say the FDA need…
- FDA expands Jazz's Ziihera use to frontline gastric cancerFDA granted approval for Jazz Pharmaceuticals' bispecific antibody Ziihera as a frontline treatment for certain gastric cancer patients. This is the first time Ziihera will be marketed to newly di…