QRxPharma, an Australian-based commercial-stage specialty pharmaceutical company, has resubmitted its MOXDUO new drug application (NDA). At a meeting in early October 2013, the US Food and Drug Administration (FDA) provided QRxPharma with ...
Tags: QRxPharma, Drug Application
A research paper published in the scientific journal Tobacco Control shows that graphic warning labels on cigarette packs led to a decrease in smoking rates in Canada of between 12% and 20% from 2000 to 2009. The authors estimate that if ...
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
US-based Boston Scientific has obtained an approval from the US Food and Drug Administration (FDA) for its Promus PREMIER everolimus-eluting platinum chromium coronary stent system. The company's next-generation durable polymer ...
US-based BioMarin Pharmaceutical has announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted in favor of approval of Vimizim for the treatment of Morquio A ...
Germany-based Bayer HealthCare and US-based Onyx Pharmaceuticals have announced that the US Food and Drug Administration (FDA) has approved Nexavar (sorafenib), an oral multi-kinase inhibitor, for the treatment of patients with ...
Kinetic Concepts (KCI) has obtained the US Food and Drug Administration (FDA) approval for its next generation V.A.C.Via negative pressure wound therapy system. The V.A.C.Via therapy system is a single-patient-use, ultra-portable V.A.C. ...
Tags: Therapy System, Medicine
Mauna Kea Technologies, the maker of Cellvizio, has announced the granting of the CE Mark and the pre-launch of a comprehensive range of probes aimed at endourological applications, to coincide with its first participation in the 107th ...
Pfizer has secured regular approval from the US Food and Drug Administration (FDA) for its Xalkori (crizotinib) capsules to treat patients with metastatic ALK-positive non-small cell lung cancer (NSCLC). The approval was based on ...
AtriCure, a developer of solutions to treat atrial fibrillation (Afib), has announced the US Food and Drug Administration’s (FDA) approval to begin enrollment in a clinical study of its AtriClip left atrial appendage exclusion system. ...
Tags: AtriCure, Stroke Prevention
Fenwal, a Fresenius Kabi company, has received the US Food and Drug Administration (FDA) 510(k) clearance for the Alyx system software version 3.1. The new software gives the Alyx system a protocol for closed system plasma collection and ...
US-based Dallen Medical has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Tensyn band, designed for the fixation of ankle syndesmosis. Previously, the company has obtained FDA 510(k) clearances for its ...
Tags: Dallen Medical, Tensyn Band
Biotronik, a manufacturer of cardiovascular medical devices, has obtained the US Food and Drug Administration (FDA) approval for Phase B of the company’s ongoing ProMRI clinical trial. Biotronik has recently completed Phase A of the ...
Tags: Promri Clinical Trial, Biotronik
The US Food and Drug Administration (FDA) has approved Janssen Therapeutics' NS3/4A protease inhibitor 'Olysio (simeprevir)' for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with ...
US-based specialty pharmaceutical firm Impax Laboratories (Impax) has started shipment of generic Solaraze (diclofenac sodium gel, 3%), a first-to-file product, through its generics division Global Pharmaceuticals. In order to ...