Industry Dynamics

Industry News

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: 乐卫玛®, generic nam……

10-09

2018

FYCOMPA® NEWLY APPROVED BY U.S. FDA AS TREATMENT FOR PARTIAL-ONSET SEIZURES IN PEDIATRIC PATIENTS WITH EPILEPSY

Eisai Co., Ltd. announced today that its U.S. subsidiary Eisai Inc. received approval from the U.S. Food and Drug Administration (FDA) for an indication expansion for Eisai's antiepileptic drug (AED) Fycompa (perampa……

09-30

2018

China National Drug Administration grants rapid approval of Roche’s Alecensa (alectinib) as a treatment for ALK-positive lung cancer

Roche today announced that the China National Drug Administration (CNDA) has granted marketing authorisation for Alecensa® (alectinib) as a monotherapy treatment for patients with anaplastic lymphoma kinase (ALK)-positiv……

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