Kite Submits Supplemental Biologics License Application to U S Food and Drug Administration for Tecartus® in Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia investingnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from investingnews.com Daily Mail and Mail on Sunday newspapers.
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Humanigen Reports Fourth Quarter and Year-End 2020 Financial Results and Provides Corporate Update
March 10, 2021 GMT
BURLINGAME, Calif. (BUSINESS WIRE) Mar 10, 2021
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab™, today reported financial results for the year ending December 31, 2020 and announced objectives for 2021.
“We are proud of all the advances Humanigen made in 2020, not just as a company, but as a key player in the development of an effective treatment for hospitalized COVID-19 patients,” said Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen. “We were able to take lenzilumab from the context of preventing and treating cytokine storm in other therapeutic categories and adapt it at unpr
U S FDA Approves Yescarta® for Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy investingnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from investingnews.com Daily Mail and Mail on Sunday newspapers.
Posted on 17160
Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Yescarta
® (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The approval makes Yescarta the first chimeric antigen receptor (CAR) T-cell therapy approved for patients with indolent follicular lymphoma, follows FDA Breakthrough Therapy Designation and a priority review, and marks the third approved indication for a Kite cell therapy.
The approval is based on results from ZUMA-5, a single-arm, open-label study in which 91 percent of patients with relapsed or refractory FL (n=81) responded to Yescarta, including an estimated 74 percent of patients in a continued remission at 18 months (Kaplan-Meier estimate). Among all FL patients, median duration of response
U S FDA Approves Yescarta for Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy wallstreet-online.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from wallstreet-online.de Daily Mail and Mail on Sunday newspapers.