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 ...
Eisai Europe has become a signatory to the Tuberculosis Drug Accelerator (TBDA) partnership, an initiative that aims to speed up the discovery of essential new treatments for tuberculosis (TB). Launched in June 2012 through a ...
The U.S. Food and Drug Administration approved the first adjuvanted pandemic influenza vaccine, Q-pan, to protect against H5N1 influenza, or avian flu. The vaccine, manufactured by GlaxoSmithKline, was developed in partnership with the ...
The RNS device receiced FDA approval via the PMA pathway. NeuroPace (Mountain View, CA) landed FDA PMA approval for its RNS Stimulator, a device that can detect and treat patients suffering from drug-resistant epilepsy. Seizures occur ...
Tags: RNS, FDA approval, PMA pathway, NeuroPace
Belgium-based biopharmaceutical firm ThromboGenics has announced that its partner Alcon has launched Jetrea (ocriplasmin) for the treatment of symptomatic vitreomacular adhesion (VMA) in Canada. According to the company, Canada is the ...
Tags: Alcon, Vitreomacular Adhesion
Covalon Technologies, an advanced medical technologies company, will showcase new wound healing and infection management products at MEDICA medical technology trade fair, 20 November to 23 November in Dusseldorf, Germany. The latest ...
Tags: Covalon, Wound Healing Products
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 ...
US-based Moderna Therapeutics has announced the completion of a new financing round, raising $110m to develop messenger RNA Therapeutics. In aggregate, Moderna has secured more than $415m in financing and partnerships to date from the ...
GlaxoSmithKline (GSK) and Amicus Therapeutics have announced that Amicus has received global rights for the global drug development, regulatory and commercial activities of migalastat HCl as a monotherapy and in combination with enzyme ...
Tags: GlaxoSmithKline, Fabry Agreement
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