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 ...
Swiss drugmaker Novartis has announced that once-daily dual bronchodilator, Ultibro Breezhaler (QVA149), has achieved positive CHMP opinion for the treatment of chronic obstructive pulmonary disease (COPD). Ultibro Breezhaler was ...
Japan-based Takeda Pharma has received positive CHMP opinion for its three new type 2 diabetes therapies from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The therapies include Vipidia ...
Tags: Therapies, CHMP Opinion
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 ...
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
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 ...
The European Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinion for Aegerion Pharmaceuticals' marketing authorization for Lojuxta (lomitapide) hard capsules. If approved, Lojuxta will be indicated for adult ...
Tags: Marketing Authorization, Medicine
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
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 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'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 ...
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Novartis Ilaris for use in acute gouty arthritis patients who are not suitable for current treatments. The only ...
Tags: Medicinal Products, therapies, treatments
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 ...