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Celltrion: COVID-19 antibody treatment effective against Delta variant

Celltrion: COVID-19 antibody treatment effective against Delta variant
biopharma-reporter.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from biopharma-reporter.com Daily Mail and Mail on Sunday newspapers.

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FibroGen Announces Outcome of FDA Advisory Committee Review of Roxadustat for Treatment of Anemia of Chronic Kidney Disease

 > Nachricht FibroGen Announces Outcome of FDA Advisory Committee Review of Roxadustat for Treatment of Anemia of Chronic Kidney Disease Nachrichtenquelle: globenewswire  |  16.07.2021, 00:26  |  102   |  0  SAN FRANCISCO, July 15, 2021 (GLOBE NEWSWIRE) FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted to recommend not approving roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, for the treatment of anemia due to chronic kidney disease (CKD) in adult patients. The Committee based its recommendation on data from a global Phase 3 program encompassing more than 8,000 patients. While the FDA is not required to follow the Committee s vote, the

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HUTCHMED's Marketing Authorization Application for Surufatinib Submitted and Validated by the European Medicines Agency

Share: – EMA commences review of surufatinib for the treatment of advanced neuroendocrine tumors – – Expands potential global reach of surufatinib, in addition to China where it is already launched, and in the U.S. where it is under review for marketing approval – HONG KONG, SHANGHAI, China and FLORHAM PARK, N.J., July 15, 2021 (GLOBE NEWSWIRE) HUTCHMED (China) Limited ( HUTCHMED ) (Nasdaq/AIM: HCM; HKEX: 13) today announces that the European Medicines Agency ( EMA ) has validated and accepted its marketing authorization application ( MAA ) for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors ( NETs ). The EMA s validation confirms that the submission is sufficiently complete and that it is ready to commence the formal review process.

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Investegate |Hutchmed China Ltd Announcements | Hutchmed China Ltd: Surufatinib MAA Submitted and Validated by the EMA

Investegate |Hutchmed China Ltd Announcements | Hutchmed China Ltd: Surufatinib MAA Submitted and Validated by the EMA
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bluebird bio, Inc.: bluebird bio Announces Positive Recommendation by PRAC Regarding Article 20 Safety Referral Review of ZYNTEGLO Gene Therapy for Transfusion-Dependent ß-thalassemia and Marketing to Resume in EU

bluebird bio, Inc.: bluebird bio Announces Positive Recommendation by PRAC Regarding Article 20 Safety Referral Review of ZYNTEGLO Gene Therapy for Transfusion-Dependent ß-thalassemia and Marketing to Resume in EU
finanznachrichten.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from finanznachrichten.de Daily Mail and Mail on Sunday newspapers.

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