Danish pharmaceutical company H. Lundbeck and Japanese drugmaker Otsuka Pharmaceutical have announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing approval for ...
Medical device company Teleflex has introduced ARROW JACC (jugular axillo-subclavian central catheter), a small-french size antimicrobial and antithrombogenic catheter designed for both acute and long-term use, with Chlorag+ard technology. ...
Health Canada has accepted to review Sunovion Pharmaceuticals Canada's (Sunovion) new drug submission (NDS) for eslicarbazepine acetate for use as a once-daily adjunctive therapy for the treatment of partial-onset seizures in patients aged ...
The European Medicines Agency (EMA) has received an application from Bayer HealthCare for marketing authorization of its oral multi-kinase inhibitor, regorafenib, for the treatment of patients with gastrointestinal stromal tumors (GlST). ...
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
Coherex Medical, a developer of medical devices, has obtained CE Mark approval for its Coherex WaveCrest left atrial appendage (LAA) occlusion system. WaveCrest LAA Occluder seals off the LAA opening so that blood clots cannot escape into ...
Tags: Coherex Medical, CE Mark
CardioKinetix has announced the first successful procedure in four cardiac patients with its new catheter-based Parachute ventricular partitioning device in Kuala Lumpur, Malaysia. The new Parachute device is a new minimally invasive ...
Japanese pharmaceutical firm Eisai Co, through its South Korean marketing subsidiary, has rolled out a higher-dose, once-daily Aricept (donepezil hydrochloride) 23mg tablet formulation used to treat moderate-to-severe Alzheimer's disease ...
Tags: pharmaceutical firm, Medicine
The US Food and Drug Administration (FDA) has issued Breakthrough Therapy Designation for Catalyst Pharmaceutical Partners’ Firdapse (amifampridine phosphate), which is used to treat patients with Lambert-Eaton Myasthenic Syndrome ...
Tags: Therapy Designation, Medicine
Medical device company LDR has received approval from the US Food and Drug Administration (FDA) for commercial sale and distribution of its Mobi-C Cervical Disc (Mobi-C), for two-level indications in the US. The Mobi-C is designed for ...
Tags: Medical device, LDR
Bayer HealthCare and Onyx Pharmaceuticals have announced FDA priority review designation for Nexavar (sorafenib) supplemental new drug application for the treatment of radioactive iodine-refractory differentiated thyroid cancer. Nexavar ...
Tags: New Drug Application, FDA
Medical technology company Lombard Medical Technologies successfully treated the first US patients with Aorfix, its flexible stent graft for the endovascular repair of abdominal aortic aneurysms (AAAs). Meriter Hospital vascular surgeon ...
Tags: Aortic Stent Graft
The European Commission has granted additional indication for GlaxoSmithKline’s (GSK) Tyverb (lapatinib) in combination with trastuzumab for adult patients with overexpress HER2 (ErbB2), with hormone receptor-negative (HR-) metastatic ...
Tags: European Commission
US generics drug maker Actavis has rolled out new formulations of Fioricet (butalbital, acetaminophen and caffeine capsules, USP) and Fioricet with Codeine (butalbital, acetaminophen, caffeine and codeine phosphate, USP). Both medicines ...
InSightec has received approval from the Chinese Food and Drug Administration (CFDA) for its ExAblate system designed to treat uterine fibroids non-invasively. This system uses high intensity focused ultrasound energy to destroy the ...
Tags: InSightec, Ultrasound System