THE DRUG DOCKETThe FDA logged a Class I recall of Ventec's VOCSN, V+Pro, VC and V*Home ventilators on 28 October, citing an internal cable connector that can detach, rebooting the device and interrupting breathing support.
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THE DRUG DOCKETOn 21 October the agency added ravulizumab's fifth indication - cutting protein leakage in adults at risk of progression - but granted it on a surrogate alone, with no proof yet that it slows kidney decline.
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THE DRUG DOCKETA 23 October label change adds a 720 mg subcutaneous starting course at weeks 0, 2, 4 and 8, letting patients begin risankizumab without the three intravenous infusions the drug has required since 2022.
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WHAT THE STUDY ACTUALLY SAYSIn STOP-V1 and STOP-V2, oral povorcitinib roughly tripled the share of adults reaching 75% facial repigmentation at a year — but even on the drug, fewer than one in five got there.
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