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- Gilead places CAR-T program on partial hold after ICANS cases; Agios delays PDUFA submissionGilead announced a partial clinical hold on its CAR-T therapy after several patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS). The hold will pause enrollment and…
- New PDUFA agreement earmarks funds to rehire FDA reviewers after recent layoffsTrade groups report that the latest PDUFA reauthorization includes a specific funding pool for the FDA. The money is intended to replace reviewers who were let go after recent HHS staffing reducti…