The approval is based on a large multi-center non-inferiority study demonstrating that TNKase is comparable to Activase in AIS patients in terms of safety and efficacy. The AcT (Alteplase compared ...

The US Food and Drug Administration has approved TNKase (tenecteplase), a thrombolytic or clot-dissolving agent.

SOUTH SAN FRANCISCO, Calif., March 03, 2025--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA ...

This approval of TNKase marks Genentech’s second approval for stroke, reinforcing the company's long-standing dedication to advancing stroke care as the developer of the only two FDA-approved ...

It is the second FDA-approved treatment for acute ischemic stroke, the other being Activase (alteplase), also manufactured by Genentech, the release said. Tenecteplase is the first acute ischemic ...

This is considerably faster than the standard of care, Activase (alteplase), which is administered as an intravenous bolus followed by a 60-minute infusion. Genentech, the manufacturer of TNKase ...

TNKase will be available for the treatment of acute ischemic stroke in adults, joining the Roche subsidiary’s Activase (alteplase) on the market – also approved for the same indication.