FDA, Genentech and lupus nephritis

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.
FDA Accepts Supplemental Biologics License Application for Gayzva for Treatment of Lupus Nephritis
The U.S. Food and Drug Administration (FDA) has accepted Genentech’s Supplemental Biologics License Application (sBLA) for Gazyva® (Obinutuzumab), for the potential treatment of lupus nephritis, (LN,
Genentech wins FDA approval for second stroke treatment
Genentech’s label expansion for TNKase consolidates its market position for pharmacological stroke treatments.
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
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.
FDA Accepts RHHBY's sNDA for Gazyva in Treating Lupus Nephritis
Roche RHHBY announced that the FDA has accepted its supplemental new drug application (sNDA) seeking label expansion for its blockbuster drug Gazvya (obinutuzumab) as a potential treatment for lupus nephritis (LN).
EMS12d
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 ...
Medscape5d
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 ...
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 ...
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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 ...
Genentech announces FDA approval of TNKase in acute ischemic stroke
Genentech announced that the U.S. Food and Drug Administration has approved TNKase, a thrombolytic or clot-dissolving agent, for the treatment ...
WebMD5d
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.
Fierce Pharma6d
Roche gains label expansion for heart attack medicine TNKase to treat acute ischemic stroke
Genentech has had the lone medicine on the market for the acute treatment of stroke. | Over nearly the last three decades, ...