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FDA grants priority review tag to JNJ's nipocalimab BLA for gMG and asks for new warnings on GSK & PFE's RSV vaccine labels.
The temporary pause follows reports of four cases of neurovascular events in the US external evaluation study.
Johnson & Johnson halted the limited rollout of its Varipulse pulsed field ablation system on Jan. 5 to “investigate the root causes of four reported neurovascular events in the U.S. external ...
Johnson & Johnson pauses U.S. Varipulse cases to investigate neurovascular events. The FDA-approved device integrates PFA ...