The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's (GSK) first adjuvanted vaccine for the prevention of H5N1 influenza, also known as avian or bird flu. The pandemic Influenza A (H5N1) Virus Monovalent Vaccine, ...
Tags: Bird Flu Vaccine, GlaxoSmithKline
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
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
Allergan has received a positive opinion for its Vistabel (botulinum toxin type A) from France's National Security Agency of Medicines and Health Products (ANSM) to treat moderate to severe crow's feet lines in adult patients. The ...
Tags: Allergan, Crow's Feet Lines
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
US-based pharmaceutical firm Merck has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for its investigational oral combination regimen MK-5172/MK-8742 for the treatment of chronic hepatitis C virus ...
Danish pharmaceutical firm Novo Nordisk has received biologics licence application (BLA) approval from the US Food and Drug Administration (FDA) for its recombinant coagulation factor VIII, Novoeight. Novoeight is intended for adults and ...
Tags: Novo Nordisk, Drug
The US Food and Drug Administration (FDA) has approved Antares Pharma's (Antares) OTREXUP, a single-dose, disposable auto-injector for the subcutaneous (SC) once-weekly administration of methotrexate (MTX). OTREXUP is reportedly the first ...
The US Food and Drug Administration (FDA) has accepted to review AstraZeneca's new drug application (NDA) for Epanova, an investigational compound for the treatment for patients with severe hypertriglyceridaemia. Omthera Pharmaceuticals, ...
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
US-based pharmaceutical manufacturer and marketer Forest Laboratories (FRX) has received qualified infectious disease product (QIDP) designation for its ceftazidime/avibactam drug from the US Food and Drug Administration (FDA). Currently ...
Tags: drug, Forest Laboratories
Celgene has received approval from the US Food and Drug Administration (FDA) for its drug 'Abraxane' to treat patients with late-stage adenocarcinoma of the pancreas. Adenocarcinoma is a sub-type of exocrine tumors which accounts for ...
The US Food and Drug Administration (FDA) has scheduled a meeting on 03 October 2013 to discuss QRxPharma's Moxduo new drug application (NDA) for the treatment of moderate to severe acute pain. The meeting is aimed at focusing on ...
Tags: Acute Pain Drug
The US Food and Drug Administration (FDA) has accepted for review the complete response submission made by Endo Health Solutions' subsidiary Endo Pharmaceuticals to the new drug application (NDA) for its testosterone undecanoate injection ...
Tags: Aveed Injection, Medicine
Global health care company Fresenius Kabi USA has rolled out its Levofloxacin in 5% Dextrose injection in freeflex containers, designed for better infusion of solutions. Considering easy handling with improved safety and environmental ...
Tags: Fresenius Kabi, Freeflex Container