GlaxoSmithKline (GSK) and Theravance have received marketing authorization from the European Commission (EC) for their jointly-developed asthma and chronic obstructive pulmonary disease (COPD) drug 'Relvar Ellipta'. Relvar, which is a ...
Tags: GSK, Relvar Ellipta
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), ...
Bayer HealthCare has received marketing authorization from the European Commission (EC) for its Xofigo injection for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral ...
Boehringer Ingelheim has submitted European marketing authorization applications (MAA) to extend the indication to use tiotropium (Spiriva) Respimat for the treatment of asthma in adults aged 18 years and over. The MAA is based on results ...
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
US-based biopharmaceutical company MannKind has resubmitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking marketing authorization for its AFREZZA inhalation powder, indicated to improve glycemic control ...
Tags: Insulin Application, biopharmaceutical company MannKind
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
US-based LabStyle Innovations has obtained CE Mark approval for its Dario smartphone-based glucose monitor and comprehensive diabetes management system. Particularly useful for insulin-dependent patients, the system provides patients, ...
GlaxoSmithKline and biopharmaceutical company Theravance have announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing approval for fluticasone furoate/vilanterol ...
NeoTract has received an approval from the US Food and Drug Administration (FDA) to market its UroLift system, designed to relieve low or blocked urine flow in men age 50 and older with an enlarged prostate (benign prostatic hyperplasia). ...
Tags: Prostate Implant, Neotract