A year after receiving approval by the Food and Drug Administration, the new weight-loss drug Belviq is finally available by prescription. But you may not want to rush out and get it. It's only approved for people who are obese, with a ...
The European Medicines Agency has cleared Roche's RoACTEMRA for the treatment of a rare form of arthritis, polyarticular juvenile idiopathic arthritis (PJIA), in children aged two years and above. Approved for use alone or in combination ...
Tags: Arthritis Drug, Medicine
Takeda Pharmaceutical Company, AMAG Pharmaceuticals' European commercial partner, has submitted a type-II variation to the European Medicines Agency (EMA) for label expansion of Rienso (ferumoxytol). The approval will allow the use of ...
Tags: Takeda, EMA Approval
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Celgene International's oral anti-cancer therapy Pomalidomide. The positive results from the MM-003 study of ...
Astellas Pharma and Medivation have announced the Health Canada approval of Xtandi (enzalutamide) capsules to treat metastatic castration-resistant prostate cancer. The oral, once-daily androgen receptor inhibitor is indicated for ...
Tags: Astellas Pharma, Medicine
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
Biogen Idec is seeking FDA approval for Plegridy (Peginterferon Beta-1a) as multiple sclerosis (MS) medication. The company submitted a biologics license application (BLA) to the FDA for its pegylated subcutaneous injectable candidate ...
Tags: Biogen IDEC, FDA Approval
Oncology-focused company Curis has announced the approval of Erivedge (vismodegib) in Australia for the treatment of metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma in adult patients who are not suitable for ...
Tags: Curis, Erivedge Anti-Cancer Drug
Meda Pharmaceuticals has announced the availability of nasal spray formulation of fluticasone propionate and azelastine hydrochloride, Dymista, on prescription in the UK. Dymista is indicated for the symptomatic treatment of moderate to ...
Tags: Meda Dymista, Medicine
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has announced positive opinion for conditional approval of Curis' Erivedge in European Union. Erivedge (vismodegib) is used to treat adults with ...
The European Commission has approved Sanofi Pasteur's 6-in-1 pediatric vaccine Hexyon/Hexacima (DTaP-IPV-Hib-HepB vaccine) for primary and booster vaccination of infants from six weeks of age. The EC decision follows the European ...
Tags: Pediatric Vaccine, Medicine
The European Commission has asked European Medicines Agency (EMA) to provide advice on the impact of antibiotic use in animals on public health and animal health. The request was made by the Commission as a part of it's 'Action Plan ...
Tags: Antibiotics in Animals, Food
The European Medicines Agency (EMA) has accepted Shionogi's marketing authorisation application (MAA) for ospemifene. Ospemifene is developed as as vulvar and vaginal atrophy (VVA) therapy in post-menopausal women. Shionogi CEO Takashi ...
Tags: EMA, Medicines, ospemifene
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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Genzyme's oral Aubagio (teriflunomide) for relapsing-remitting multiple sclerosis (MS). Aubagio did not ...