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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…
- Rare disease reform, CMC risk, reshoring US trials top of mind ahead of PDUFA VIII meetingThe FDA gathers Wednesday to hear what industry stakeholders and the public want included in the latest iteration of the Prescription Drug User Fee Act that sets the agency’s priorities for fiscal…