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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 to frontline HER2-positive gastroesophageal cancers, unlocking $1.5 billion marketThe U.S. Food and Drug Administration has broadened the approved use of Jazz Pharmaceuticals' cancer therapy Ziihera. The drug can now be given as an initial treatment for patients with HER2‑positi…