US-based NeuroPace has received the US Food and Drug Administration (FDA) premarket approval for its NeuroPace RNS system, designed to treat partial onset seizures that have not been controlled with two or more antiepileptic medications in ...
Tags: RNS System, NeuroPace
US Food and Drug Administration (FDA) has urged manufacturers to replace the label and packaging of certain over-the-counter (OTC) topical antiseptic products to improve safety. The move is part of the ongoing evaluation of infrequent ...
Tags: Packaging Process
Johnson & Johnson (JNJ) subsidiary Janssen Biotech and Pharmacyclics (PCYC) have won approval from the US Food and Drug Administration (FDA) for their breakthrough therapy Imbruvica (ibrutinib) to treat patients with mantle cell lymphoma ...
Tags: Johnson&Johnson, MCL Patients
France-based Synapse Biomedical has obtained the Health Canada approval for its NeuRx diaphragm pacing system (DPS) for ventilator-dependent spinal cord injury (SCI) patients who lack voluntary control of their diaphragms. Synapse ...
Tags: Synapse Biomedical, Neurx DPS
The US Food and Drug Administration (FDA) has accepted for review US-based biopharmaceutical firm NPS Pharmaceuticals' supplemental new drug application (sNDA) for Gattex (teduglutide [rDNA origin]) for injection. In the US, Gattex is ...
Tags: FDA, biopharmaceutical
Alnylam Pharmaceuticals, a RNAi therapeutics company, announced that the US Food and Drug Administration (FDA) has granted fast track designation to patisiran (ALN-TTR02) for the treatment of transthyretin (TTR)-familial amyloid ...
Tags: Alnylam, Fast Track Designation
Alphaeon, a wholly-owned subsidiary of Strathspey Crown Holdings, has acquired an exclusive US license from Schwind eye-tech solutions to market the AMARIS excimer laser system, for an undisclosed amount. The laser system, launched in ...
Tags: Alphaeon, Vision Correction
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
Canada-based Titan Medical has recently commenced tissue testing that was successful in assessing and measuring the functionality of the SPORT (single port orifice robotic technology) surgical system. The company will perform a sequence ...
Corgenix Medical, a developer of diagnostic test kits, has filed pre-market notification with the US Food and Drug Administration under Section 510(k) of the US Federal Food, Drug and Cosmetic Act for its hyaluronic acid (HA) enzyme-linked ...
Tags: Corgenix Medical
NanoString Technologies, a provider of life science tools for translational research and molecular diagnostic products, has announced the availability of the nCounter Dx analysis system for high-complexity, CLIA-certified laboratories. ...
Tags: NanoString, DX Analysis System
Skyline Medical, formerly BioDrain Medical, has made new enhancements to its flagship product STREAMWAY system. The US Food and Drug Administration approved STREAMWAY system is designed to improve safety and efficiency in the operating ...
Tags: Skyline Medical, Streamway System
Discovery Laboratories, a specialty biotechnology company dedicated to advancing a new standard of respiratory critical care, has announced that the US Food and Drug Administration (FDA) has cleared the company's investigational new drug ...
Tags: Discovery Labs, Medicine
Lupin Pharmaceuticals (LPI), a US subsidiary of India-based Lupin, has launched its generic Rabeprazole Sodium delayed-release tablets, 20mg. Earlier, the company had received final approval from the US Food and Drug Administration (FDA) ...
Tags: Lupin Pharma, tablets
Israeli bio-medical engineering company ITGI Medical has signed a strategic cooperation agreement with Vascular Solutions, a medical device company, to commercialize ITGI's Aneugraft Dx coronary covered stent in the US market. Pursuant to ...
Tags: ITGI Medical, Aneugraft DX Stent