Gilead Sciences has announced that the US Food and Drug Administration (FDA) has approved Sovaldi (sofosbuvir) 400mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection ...
Tags: Gilead Sciences, Chronic Hepatitis
The European Medicines Agency (EMA) has fully validated and granted accelerated assessment to Boehringer Ingelheim's application for European marketing authorization of faldaprevir, a potent second generation oral protease inhibitor. ...
Denmark-based Novo Nordisk has announced that the European Medicines Agency (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of the NovoRapid PumpCart in Europe. NovoRapid PumpCart is a 1.6ml ...
European Medicines Agency's (EMA) the Committee for Medicinal Products for Human Use (CHMP) has issued positive opinion for AstraZeneca and Bristol-Myers Squibb's of Xigduo for adults aged 18 and older with type 2 diabetes mellitus. The ...
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), ...
Manufacturers of heavy-duty commercial trucks and engines worldwide have endorsed a harmonized global approach as an effective pathway to further improving energy efficiency and reducing greenhouse gas emissions from commercial vehicles. ...
Tags: Engine, vehicle, manufacturer, fuel, efficiency
The US Food and Drug Administration (FDA) has accepted for review US-based biopharmaceutical firm NPS Pharmaceuticals' supplemental new drug application (sNDA) for Gattex (teduglutide [rDNA origin]) for injection. In the US, Gattex is ...
Tags: FDA, biopharmaceutical
NanoViricides has secured orphan drug designation from the European Medicines Agency (EMA) for its drug candidate DengueCide, for the treatment of dengue and dengue hemorrhagic fever. Dengue fever is a mosquito-borne disease that affects ...
Tags: Nanoviricides Drug
H Lundbeck has expanded its current alliance with Otsuka Pharmaceutical (Otsuka) to include development and commercialization of nalmefene in Japan. Earlier in 2013, nalmefene was approved by the European Medicines Agency (EMA) as the ...
Tags: Lundbeck, Otsuka Pharmaceutical
The US Food and Drug Administration (FDA) has approved Roche's new drug Gazyva (obinutuzumab) in combination with chlorambucil chemotherapy for treatment of patients with chronic lymphocytic leukemia (CLL) who have not previously been ...
Tags: Combination Vaccine, Medicine
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