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Industry Dynamics

Industry News

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……

09-28

2018

Lynparza receives approval in Japan for the treatment of advanced ovarian cancer

AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) announced that the Japanese Ministry of Health, Labour and Welfare has approved Lynparza (olaparib) tablets (300mg twice dail……

07-09

2018

UCB announces approval of NEUPRO? in China to treat Parkinson’s Disease

Belgium-based global bio-pharmaceutical company UCB today announced it has received an Import Drug License (IDL) from the China Food and Drug Administration (CFDA), creating a pathway to make the company’s 24-hour contin……

06-29

2018

FDA approves Roche’s Avastin (bevacizumab) plus chemotherapy as a treatment for women with advanced ovarian cancer following initial surgery

Roche today announced that the US Food and Drug Administration (FDA) has approved Avastin? (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for the treat……

06-04

2018

China Drug Administration Approves Epclusa? (Sofosbuvir/Velpatasvir), Gilead’s Pan-Genotypic Treatment for Chronic Hepatitis C Virus Infection

Gilead Sciences, Inc. announced today that the China Drug Administration (CDA) has approved Epclusa? (sofosbuvir 400 mg/velpatasvir 200 mg) for the treatment of adults with genotype 2-6 chronic hepatitis C virus (HCV) in……

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