Eisai has filed an application for the proton pump inhibitor Pariet in Japan looking for a further indication expansion for use in the prevention of recurrent gastric or duodenal ulcer caused by low-dose aspirin therapy as well as the ...
Baxter International has initiated a voluntary recall of one lot of Nitroglycerin in 5% Dextrose injection due to particulate matter found in one vial. If infused, particulate matter could lead to potential venous and/or arterial ...
Tags: Dextrose Injection, Medicine
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 ...
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
The U.S. Food and Drug Administration warns doctors of the rare but serious risk of heart attack and death with use of the cardiac nuclear stress test agents. The cardiac nuclear stress test agents Lexiscan, or regadenoson, and Adenoscan, ...
US-based Salix Pharmaceuticals has announced that The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has approved the Deflux premarket approval (PMA) supplement, which requested approval of ...
Tags: Salix, Injection Techniques
Valeant Pharmaceuticals North America, a wholly-owned subsidiary of Valeant Pharmaceuticals International, has received a notice that the new drug application for Luzu (luliconazole) cream, 1% has been approved by the US Food and Drug ...
Volcano, a developer and manufacturer of precision guided therapy tools, has announced the commercial release and initial implantations of its new Crux vena cava filter (VCF) in patients at risk for recurrent pulmonary embolism (PE). It ...
Tags: Volcano, therapy tools
Austria-based Miracor Medical Systems has announced that 30 patients have been successfully treated with no device-related adverse events using its PICSO (pressure-controlled intermittent coronary sinus occlusion) system designed to improve ...
Tags: PICSO System, Medical Systems
Medtronic has obtained an investigational device exemption from the US Food and Drug Administration (FDA) to initiate SYMPLICITY HTN-4 clinical trial using its Symplicity renal denervation system. SYMPLICITY HTN-4 study has been designed ...
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
Pharmaceutical companyc Food and Drug Administration (FDA) has approved Zohydro ER (hydrocodone bitartrate) extended-release capsules. Zohydro ER is an opioid agonist, extended-release oral formulation of hydrocodone without ...
Chinese specialty pharmaceutical firm Eddingpharm has received an exclusive, royalty-bearing license from Ablynx to develop and commercialize its anti-RANKL Nanobody, ALX-0141, in China, the Hong Kong and Macao Special Administrative ...
Tags: Eddingpharm, Anti-Rankl Nanobody
PLC Systems, a medical device company, has obtained an approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to initiate a single-arm clinical trial in Japan using its RenalGuard therapy. This approval is based on MHLW's ...
Tags: PLC Systems, Renalguard Therapy
Medtronic, a US-based manufacturer of implantable heart-rhythm devices, has obtained the US Food and Drug Administration (FDA) approval for the Complete SE (self-expanding) vascular stent for use in superficial femoral artery (SFA) and ...
Tags: Medtronic, Lower Extremities