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- FDA outlines new onshoring incentives and meeting types for generic drug applicants under GDUFA IVThe FDA released its GDUFA IV commitments, indicating that review timelines for generic drug submissions will remain largely consistent through 2032, mirroring the schedule of the previous five yea…
- Silence Therapeutics' Phase 2 trial shows strong results for divesiran in polycythemia vera, shares jump 30%Silence Therapeutics reported that its nucleic‑acid drug divesiran achieved a 69% placebo‑adjusted response rate in a Phase 2 study of polycythemia vera patients. Safety was reported as clean, with…