Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug ...
TNKase — tenecteplase — is the first FDA-approved stroke medicine in nearly 30 years, offering a faster, simpler five-second ...
Genentech announced that the U.S. Food and Drug Administration has approved TNKase, a thrombolytic or clot-dissolving agent, for the treatment ...
Tenecteplase is administered as a single, 5-second intravenous bolus, providing a faster and simpler option compared to the ...
Genentech’s label expansion for TNKase consolidates its market position for pharmacological stroke treatments.
The approval was supported by data from the registry-linked, parallel group, open-label, randomized AcT trial, which compared tenecteplase to alteplase.
Notably, off-label tenecteplase had already become the preferred thrombolytic for acute ischemic stroke before the expanded ...
The U.S. Food and Drug Administration has approved TNKase (tenecteplase), a thrombolytic or clot-dissolving agent, for the ...
for the treatment of acute ischemic stroke (AIS) in adults. This approval of TNKase marks Genentech’s second approval for stroke, reinforcing the company's long-standing dedication to advancing ...
Genentech, the manufacturer of TNKase ... The approval is based on a study comparing TNKase to Activase in patients with acute ischemic stroke who presented with a disabling neurological deficit.
The approval is based on results of the AcT trial, where tenecteplase was comparable to alteplase for safety and efficacy.