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
Danish pharmaceutical company H. Lundbeck and Japanese drugmaker Otsuka Pharmaceutical have announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing approval for ...
British drugmaker AstraZeneca has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its new four-in-one flu vaccine Fluenz Tetra. Fluenz Tetra, a nasally ...
Tags: Astrazeneca, Medicine
Danish pharmaceutical company Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing approval for its NovoEight (turoctocog alfa), ...
Tags: Novo Nordisk, Novoeight
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 ...
Global clinical technology solutions provider Trifecta Clinical and SAFE-BioPharma have entered into a strategic partnership to promote use of standards-based digital identities. Under the deal, Trifecta will implement SAFE-BioPharma's ...
The European Medicines Agency (EMA) has granted an orphan drug status to US-based clinical-stage biotechnology company GlycoMimetics' GMI-1070 (rivipansel sodium), designed to treat vaso-occlusive crisis (VOC) in patients with sickle cell ...
The European Medicines Agency (EMA) has granted an orphan drug status to US-based clinical-stage biotechnology company GlycoMimetics’ GMI-1070 (rivipansel sodium), designed to treat vaso-occlusive crisis (VOC) in patients with sickle ...
Tags: Orphan Drug, Cell Drug
Biotechnology firm Alexion Pharmaceuticals has secured approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for the use of its Soliris (eculizumab) drug to treat pediatric and adult patients with atypical hemolytic ...
Tags: Ahus Treatment, Soliris Drug
The European Medicines Agency (EMA) has received an application from Bayer HealthCare for marketing authorization of its oral multi-kinase inhibitor, regorafenib, for the treatment of patients with gastrointestinal stromal tumors (GlST). ...
Celgene International's oral anti-cancer therapy Pomalidomide has won European Commission approval as treatment for patients with relapsed/refractory multiple myeloma (rrMM), a rare form of blood cancer, in combination with dexamethasone. ...
Tags: Anti-Cancer Therapy
GlaxoSmithKline (GSK) has submitted an application seeking approval from the European Medicines Agency (EMA) of a variation for Votrient (pazopanib). The approval is for additional indication for Votrient as the maintenance treatment of ...
British drugmaker GlaxoSmithKline (GSK) has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for its cervical cancer vaccine, Cervarix [Human papillomavirus bivalent (types 16 and 18) vaccine, ...
Tags: Cervarix, Schedule Application