Genentech, FDA and Gazyva
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Genentech gets FDA acceptance for its Lupus treatment's license application
FDA Accepts Supplemental Biologics License Application for Genentech’s Gazyva for the Treatment of Lupus Nephritis
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva ® (obinutuzumab) for the treatment of lupus nephritis.
Genentech receives FDA acceptance for Gazyva sBLA
Genentech, a member of Roche (RHHBY), announced that the FDA has accepted the company’s supplemental biologics license application for Gazyva
Genentech announced that the U.S. Food and Drug Administration has approved TNKase, a thrombolytic or clot-dissolving agent, for the treatment
The FDA has approved TNKase, a tissue plasminogen, clot-dissolving agent, to treat acute ischemic stroke in adults, according to the manufacturer.Genentech said in a press release that TNKase (tenecteplase) has been approved as a one-time,
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FDA approves Genentech’s TNKase® in acute ischemic stroke in adultsGenentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has approved TNKase ® (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke (AIS) in adults.
Genentech, a member of the Roche Group, announced that the FDA has approved the company’s TNKase (tenecteplase) thrombolytic
TNKase — tenecteplase — is the first FDA-approved stroke medicine in nearly 30 years, offering a faster, simpler five-second IV bolus administration
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.
(RTTNews) - Genentech, a member of the Roche Group (RHHBY ... with Gazyva plus standard therapy compared with standard therapy alone.The FDA is expected to make a decision on approval by October ...
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.
Genentech has had the lone medicine on the market for the acute treatment of stroke. | Over nearly the last three decades, Genentech has had the lone medicine on the market for stroke. On Monday, the Roche subsidiary added a second stroke treatment to its repertoire,
The approval is based on results of the AcT trial, where tenecteplase was comparable to alteplase for safety and efficacy.
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