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,
FDA accepts supplemental Biologics License Application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of 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 Biologics License Application for GSK’s Depemokimab for Asthma with Type 2 Inflammation and CRSwNP
In the SWIFT and ANCHOR trials, depemokimab demonstrated statistically significant reductions in nasal polyp size, obstruction, and asthma exacerbations compared to placebo.
Alvotech and Teva Pharmaceuticals announce FDA accepts Biologics License Application for AVT06
Alvotech and Teva Pharmaceuticals announced the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept) 2 mg.
F. Hoffmann-La Roche Ltd: FDA accepts supplemental Biologics License Application for Roche's Gazyva/Gazyvaro for the treatment of lupus nephritis
Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a complete renal response benefit1 The filing application is based on data from the phase
FDA Accepts Roche’s Supplemental Biologics License Application for Gazyva/Gazyvaro in Lupus Nephritis
Submission is supported by positive results from the Phase III REGENCY trial, which demonstrated that nearly half of patients with lupus nephritis who received Gazyva/Gazyvaro plus standard therapy achieved a complete renal response.
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
Outlook Therapeutics® Re-Submits Biologics License Application for ONS-5010 as a Treatment for Wet AMD to the U.S. Food and Drug Administration
We remain committed to bringing an ophthalmic bevacizumab to market in the United States and providing retina patients suffering from wet AMD with a much needed treatment option that has the potential ...
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Biologics and Biosimilars Landscape 2024: IP, Policy, and Market Developments
Last year marked an all-time record of 18 Food and Drug Administration (FDA) biosimilar approvals, bringing the total number ...
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ADMA Biologics Gears Up to Report Q4 Earnings: What's in the Cards?
Image Source: Zacks Investment Research ADMA’s supplemental biologics license applications (sBLAs) for both Asceniv and Bivigam were approved by the FDA last year. This extended the approved ...
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Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept)
has accepted for review a Biologics License Application (BLA) for AVT06, Alvotech’s proposed biosimilar to Eylea ® (aflibercept), a biologic used to treat eye disorders, including diseases which ...