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- FDA issues early alert on Abiomed Impella controller safety issueThe FDA Center for Devices and Radiological Health (CDRH) has posted an Early Alert about a potential high risk problem with certain Abiomed Impella automated controllers. Abiomed has sent a lette…
- Roivant's FcRn drug IMVT-1402 fails Phase 2b lupus trialRoivant announced that its FcRn-targeting antibody IMVT-1402 (imeroprubart) failed to meet primary endpoints in a Phase 2b trial in patients with lupus. The study did not show improvement in disea…