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
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
Glass Onion Catering in Richmond, Calif., recalled about 182,000 pounds of salads and wraps after 26 people got sick eating their products, officials say. The U.S. Department of Agriculture's Food Safety and Inspection Service said Sunday ...
Tags: trader, recall, glass onion, catering
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
Kush Bottles has announced that the company's bottles received approval form the United States Consumer Product Safety Commission as they meet the child-safe packaging standards. The approval has been granted in the Colorado region as ...
Tags: Kush Bottles
NanoViricides has secured orphan drug designation from the European Medicines Agency (EMA) for its drug candidate DengueCide, for the treatment of dengue and dengue hemorrhagic fever. Dengue fever is a mosquito-borne disease that affects ...
Tags: Nanoviricides Drug
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
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
A.P. Pharma, a specialty pharmaceutical company, has initiated a program to expand its pipeline of sustained release products, including a new program targeting the relief of post-surgical pain. The company also announced it will pursue a ...
Tags: A.P.Pharma, Pipeline Expansion
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