FDA approval was based on the AcT noninferiority trial that found tenecteplase (at 0.25 mg/kg) to be at least on par with alteplase for safety and efficacy in acute ischemic stroke in Canadians ...

The approval is based on results of the AcT trial, where tenecteplase was comparable to alteplase for safety and efficacy.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug ...

A major shift in stroke care is underway as tenecteplase outperforms alteplase. This new treatment could redefine recovery ...

Genentech, part of the Roche (ROG SIX) group, has received a new approval from the US Food and Drug Administration for TNKase ...

Genentech’s label expansion for TNKase consolidates its market position for pharmacological stroke treatments.

In 2023, Roche said it was removing TNKase for stroke from its phase 3 programmes after a readout of the TIMELESS trial, but ...

The approval was supported by data from the registry-linked, parallel group, open-label, randomized AcT trial, which compared tenecteplase to alteplase.

Genentech has had the lone medicine on the market for the acute treatment of stroke. | Over nearly the last three decades, ...

Genentech, a member of the Roche Group, announced that the FDA has approved the company’s TNKase (tenecteplase) thrombolytic ...

For patients with large vessel occlusion presenting between 4.5 and 24 hours, intra-arterial tenecteplase after successful ...