GlaxoSmithKline (GSK) has received the marketing authorization from Germany's Paul Ehrlich Institut (PEI) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK for its quadrivalent (four-strain) influenza vaccine. ...
Tags: GSK, Strain Influenza Vaccine
CSL Behring's Privigen has obtained marketing authorization from the European Commission for use in chronic inflammatory demyelinating polyneuropathy (CIDP). Privigen is an immune globulin intravenous [human], 10% liquid, developed for ...
Tags: CSL Behring Privigen, European Marketing Authorization
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 Commission (EC) has granted conditional marketing authorization for Pfizer's Bosulif (bosutinib) anti-cancer drug in the European Union (EU). Bosulif is authorized in Europe for the treatment of adult patients with chronic ...
Tags: Pfizer Bosulif, cancer drug, drug
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
The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted marketing authorization to Meda Pharmaceuticals' nasal spray formulation Dymista for the symptomatic treatment of moderate to severe seasonal and perennial ...
CellAegis Devices has obtained Health Canada's marketing authorization for its proprietary, automated, noninvasive device autoRIC device for remote ischemic conditioning (RIC). The Medical Device Class III license, granted by Health ...
Pfizer's bosutinib has received positive opinion for the conditional marketing authorization from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). The bosutinib positive CHMP opinion is concerned with ...
Tek Grup has entered into an agreement to distribute MagForce's NanoTherm therapy in Turkey, Albania, Iraq and Azerbaijan. The NanoTherm therapy is designed for the local treatment of solid tumors. As per the agreement, Tek Grup ...
Tags: Tek Grup, NanoTherm therapy, medical service, solid tumor
Hitachi Aloka Medical has launched a diagnostic ultrasound system with a flexible style to operate in many clinical environments. The Noblus system features the company's real-time Tissue Elastography that depicts the relative ...
Tags: Noblus Diagnostic Ultrasound System, Hitachi Aloka Medical
The Federal Ministry of Health of Germany has granted marketing authorization to pSivida for injectable, sustained-release intravitreal insert, Iluvien, designed as a treatment for vision impairment associated with chronic diabetic macular ...
Tags: Psivida, DME, clinical product
Aptalis Pharmaceutical Technologies announced that the European Commission has approved the marketing authorization of new oral granule formulation of Gilead Sciences' Viread, covering 27 countries of the European Union. Viread is ...
Tags: oral granule formulation, Pharmaceutical Technologies, Pharmaceutical
Pfizer and Ligand Pharmaceuticals have announced the FDA acceptance of bazedoxifene/conjugated estrogens (BZA/CE) new drug application (NDA) for review. The BZA/CE is an investigational therapy developed by Wyeth Pharmaceuticals to tackle ...
Tags: estrogens NDA, Pharmaceuticals, FDA, menopausal symptoms
Nipro has entered into a five-year agreement to distribute Infraredx's TVC intravascular imaging system for true vessel characterization of coronary artery disease in Japan. The TVC imaging system incorporates near infrared ...
Medivation and Astellas Pharma have announced FDA approval for Xtandi (enzalutamide) capsules to treat metastatic castration-resistant prostate cancer in patients with previously received docetaxel. Medivation and Astellas expect to make ...
Tags: Medivation, Astellas, FDA