FDA, Genentech

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.
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 wins FDA approval for second stroke treatment
Genentech’s label expansion for TNKase consolidates its market position for pharmacological stroke treatments.
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’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 adults.
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).
PMLiVE7h
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 ...
Hosted on MSN1d
Tenecteplase No Longer Off-Label as Stroke Lytic
Notably, off-label tenecteplase had already become the preferred thrombolytic for acute ischemic stroke before the expanded ...
FiercePharma2d
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, ...
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 ...
BioSpace1d
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 ...
Endovascular Today1d
Genentech’s TNKase Approved by FDA to Treat Acute Ischemic Stroke in Adults
Genentech, a member of the Roche Group, announced that the FDA has approved the company’s TNKase (tenecteplase) thrombolytic ...
Healio1d
FDA approves TNKase for acute ischemic stroke in adults
The FDA has approved TNKase, a tissue plasminogen, clot-dissolving agent, to treat acute ischemic stroke in adults, according ...
FierceBiotech6d
As Trump targets DEI practices, 4 pharmas reaffirm commitment to diversifying clinical trials
Even as President Donald Trump wages a very public fight against diversity, equity and inclusion (DEI) initiatives in the ...