Genentech gets FDA acceptance for its Lupus treatment's license application
Genentech, a Roche Group company(OTCQX:RHHBY) said on Wednesday that the U.S. FDA accepted the company’s supplemental Biologics License Application ((sBLA)) for Gazyva to treat lupus nephritis. Lupus nephritis is a type of kidney disease where the immune system attacks the kidneys.
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FDA approves clot-dissolving agent for treatment of acute ischemic stroke
TNKase — tenecteplase — is the first FDA-approved stroke medicine in nearly 30 years, offering a faster, simpler five-second IV bolus administration
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Genentech wins FDA approval for second stroke treatment
Genentech’s label expansion for TNKase consolidates its market position for pharmacological stroke treatments.
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FDA Approves TNKase for Acute Ischemic Stroke
(HealthDay News) — The US Food and Drug Administration has approved TNKase (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke in adults.
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
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FDA Approves First Biosimilar of Xolair
Celltrion’s Omlyclo is interchangeable with Xolair to treat the same conditions: asthma, chronic rhinosinusitis, food allergy and chronic spontaneous urticaria.
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FDA Okays Tenecteplase for Acute Ischemic Stroke
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.
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Genentech : FDA Accepts SBLA For Gazyva For Lupus Nephritis Treatment
(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 ...
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FDA Accepts Supplemental Biologics License Application for Genentech’s Gazyva for the Treatment of Lupus Nephritis
– Gazyva is the only anti-CD20 monoclonal antibody in a randomized Phase III study to demonstrate a complete renal response benefit – – The filing application is based on data from the Phase ...
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FDA Approves New Treatment for Stroke
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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TNKase Approved for Treatment of Acute Ischemic Stroke
The Food and Drug Administration (FDA) has approved TNKase ® (tenecteplase) for the treatment of acute ischemic stroke (AIS) in adults.
FDA Approves Genentech’s TNKase® in Acute Ischemic Stroke in Adults
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved TNKase® (tenecteplase), a thrombolytic or clot-dissolving agent,