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 ...
GlobalData on MSN5d
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 ...
PMLive4d
Roche’s Genentech granted FDA approval for TNKase in acute ischaemic stroke
Roche’s Genentech unit has received approval from the US Food and Drug Administration (FDA) for TNKase (tenecteplase) in ...
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 ...
Contract Pharma5d
Genentech’s TNKase Approved by FDA for Treatment of Strokes
The FDA has approved TNKase, a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke (AIS) in ...
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 ...
BioSpace5d
Roche Continues Regulatory Run With Acute Stroke Expansion for Heart Attack Drug
According to Roche subsidiary Genentech, which announced the label expansion on Monday, TNKase is the first new drug for ...
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 ...
Business Wire5d
FDA Accepts Supplemental Biologics License Application for Genentech’s Gazyva for the Treatment of Lupus Nephritis
--(BUSINESS WIRE)--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 ...
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 ...
Morningstar5d
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 ...