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Industry Dynamics

Industry News

01-07

2019

Horizon Pharma plc Announces FDA Approval to Expand the Age Range for RAVICTI? (glycerol phenylbutyrate) Oral Liquid to Include Newborns

Dec. 27, 2028-- Horizon Pharma plc(NASDAQ: HZNP) today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) to expand the age range for RAVICTI? (gl……

12-29

2018

I-Mab Receives U.S. FDA IND Approval for Proprietary Anti-GM-CSF Monoclonal Antibody TJM2

- The first I-Mab proprietary drug candidate to enter clinical trials in the United StatesI-Mab Biopharma (I-Mab), a China-based clinical stage biopharmaceutical company exclusively focused on the development o……

12-04

2018

FDA Freezes Imports from Chinese Maker of Tainted Valsartan

September 28, 2028 The US Food and Drug Administration (FDA) has banned imports of active pharmaceutical ingredients (API) and finished drug products produced by China's Zhejiang Huahai Pharmaceuticals……

11-29

2018

FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

On Nov.29th, The U.S. Food and Drug Administration today approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder that affects ……

11-16

2018

European Commission approves Ipsen’s Cabometyx? (cabozantinib) for the treatment of hepatocellular carcinoma in adults previously treated with sorafenib

Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the European Commission (EC) has approved Cabometyx? (cabozantinib) 20, 40, 60 mg as a monotherapy for hepatocellular carcinoma (HCC) in adults who have previou……

11-12

2018

EISAI LAUNCHES LENVIMA? (LENVATINIB) IN CHINACOMMENCES PROVIDING THE FIRST NEW THERAPY FOR UNRESECTABLE HEPATOCELLULAR CARCINOMA IN CHINA IN ALMOST A DECADE

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced that its Chinese subsidiary Eisai China Inc. (ECI) has launched the kinase inhibitor LENVIMA? (product name in China: 樂(lè )衛瑪?, generic nam……

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