Bristol-Myers Squibb (BMS) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for its investigational DCV Dual Regimen (daclatasvir and asunaprevir) for use as a combination therapy in the treatment ...
Tags: Bristol-Myers, Medicine
The European Medicines Agency (EMA) has fully validated and granted accelerated assessment to Boehringer Ingelheim's application for European marketing authorization of faldaprevir, a potent second generation oral protease inhibitor. ...
Merck has secured priority review status from the US Food and Drug Administration (FDA) for its new drug application (NDA) for an investigational intravenous (IV) solution formulation of its antifungal agent, Noxafil (posaconazole), ...
Baxter has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for approval of Rixubis, recombinant factor IX for the treatment and prophylaxis of bleeding in patients of all ages with hemophilia B. ...
Tags: Baxter, European Medicines Agency
Janssen-Cilag (Janssen), a subsidiary of Johnson & Johnson pharmaceutical firm, has submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) for the approval of once daily oral drug ibrutinib for the ...
Tags: Blood Cancer Medicine, Medicine
British drug maker GlaxoSmithKline (GSK) has received positive opinion from the European Medicines Agency (EMA's) Committee for Medicinal Products for Human Use (CHMP) for additional indication for Synflorix, a pediatric pneumococcal ...
Tags: drug, Pneumonia Indication
The US FDA's Antiviral Drugs Advisory Committee has recommended approval for Medivir's investigational protease inhibitor simeprevir (TMC435) 150mg capsules for the treatment of genotype 1 chronic hepatitis C in adult patients with ...
Tags: Medivir, Hepatitis C Patients
Eli Lilly and Company has received priority review status from the US Food and Drug Administration (FDA) for its ramucirumab (IMC-1121B) as a single-agent treatment for advanced gastric cancer following disease progression after initial ...
Tags: Cancer Drug, FDA Priority
Janssen-Cilag (Janssen) has submitted a marketing authorization application to the European Medicines Agency (EMA) for the approval of a once-daily fixed-dose antiretroviral combination tablet of HIV-1 medicine darunavir with cobicistat. ...
Tags: European Marketing, HIV-1
Boehringer Ingelheim has submitted a marketing authorisation application to the European Medicines Agency (EMA) for the approval of its oral triple angiokinase inhibitor nintedanib. Nintedanib to be used in combination with docetaxel is ...
Tags: Boehringer Ingelheim, Lung Cancer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has confirmed its opinion for European marketing authorization of Pfizer's Xeljanz (tofacitinib citrate). Xeljanz is a novel, oral Janus kinase ...
Mitsubishi Tanabe Pharma is seeking manufacturing and marketing approval of TA-7284 (generic name: canagliflozin) in Japan. The company filed a new drug application to the Ministry of Health, Labor and Welfare in Japan for TA-7284 to ...
Tags: Mitsubishi, canagliflozin
Celgene International has obtained FDA priority review status for Abraxane (paclitaxel protein-bound particles for injectable suspension) supplemental new drug application (sNDA). The application covers the use of Abraxane and gemcitabine ...
Tags: Celgene sNDA, FDA Priority
Eisai's subsidiary Eisai Laboratorios has submitted a marketing authorization application (MAA) for Belviq (lorcaserin HCl) with the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico. Arena Pharmaceuticals's ...
Tags: Eisai, Mexican Marketing, Belviq
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Gilead Sciences' marketing authorization application (MAA) for stribild. The once-daily, single tablet regimen ...
Tags: Stribild drug, Medicines, Medicine