The FDA has approved TNKase, a tissue plasminogen, clot-dissolving agent, to treat acute ischemic stroke in adults, according ...
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug ...
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Zacks.com on MSNRoche Gets FDA Approval for Acute Ischemic Stroke Drug for AdultsRHHBY's member company, Genentech, obtains FDA nod for TNKase (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke in adults.
Tenecteplase is administered as a single, 5-second intravenous bolus, providing a faster and simpler option compared to the standard 60-minute infusion of alteplase.
The approval is based on results of the AcT trial, where tenecteplase was comparable to alteplase for safety and efficacy.
According to Roche subsidiary Genentech, which announced the label expansion on Monday, TNKase is the first new drug for ...
The approval was supported by data from the registry-linked, parallel group, open-label, randomized AcT trial, which compared tenecteplase to alteplase.
For patients with acute ischemic stroke (AIS) whose symptoms began 4.5 to 24 hours earlier, alteplase is associated with a higher percentage of patients achieving a score of 0 or 1 on the modified ...
Genentech has had the lone medicine on the market for the acute treatment of stroke. | Over nearly the last three decades, ...
Genentech announced that the U.S. Food and Drug Administration has approved TNKase, a thrombolytic or clot-dissolving agent, for the treatment ...
Researchers at Karolinska Institutet have identified a new mechanism that may improve the treatment of ischemic stroke. The ...
The FDA has approved TNKase, a new, fast-acting stroke treatment that dissolves blood clots more efficiently, marking a significant advancement in stroke therapy and clot-busting technology.
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