NovaBay Pharmaceuticals has received a $1.5m equity investment from Pioneer Pharma. With the investment, Pioneer has completed $2.5m investment of total $5.5m. The investment forms part of the expansion of the NeutroPhase distribution ...
Johnson & Johnson has recalled K-Y Liquibeads vaginal lubricant from the market as US FDA insisted on additional approval for the product. The letter was issued in late May based on inspections conducted in December and January, ...
Tags: FDA, Johnson&Johnson, recall, lubricant product
Arctic Zero,a company based in Escondido,California,is voluntarily recalling pints and chocolate dipped bars as they contain undeclared milk allergen,according to the US Food and Drug Administration(FDA). The products subject to the ...
Tags: milk allergen, FDA, chocolate
Ventana Medical Systems has received FDA approval for the application of its INFORM HER2 Dual ISH DNA Probe cocktail assay (HER2 Dual ISH) on the BenchMark ULTRA automated slide staining platform. The BenchMark XT instrument, the HER2 ...
Merck Serono, a division of Merck, and Auxogyn have partnered to develop Early Embryo Viability Assessment (Eeva) test. Pursuant to the deal, Merck Serono will provide strategic, scientific and medical support for the development of ...
Tags: Early Embryo Viability Assessment test, eeva test, clinical development
GenMark Diagnostics has received 510(k) clearance from the US Food and Drug Administration (FDA) for its eSensor Respiratory Virus Panel(RVP) for use on its XT-8 system. The eSensorRVP test simultaneously detects and differentiates 14 ...
Tags: XT-8 system, FDA, clinical technology, clinical research
The FDA has granted approval for Great Basin's first molecular diagnostic test for Clostridium difficile (C. diff). The integrated cartridge system comprises necessary reagents to perform the assay and predict the presence of ...
Tags: molecular diagnostic test, clinical product, clinical research
US-based Super Store Industries has recalled its Super Duper Peanut Butter Cup ice cream over Salmonella contamination that has been associated with the Sunland peanut butter recall across the US. According to the 16 October FDA ...
Tags: Salmonella, FDA, ice cream
American multinational chemical firm Dow has announced that its Omega-9 Oils have addressed one of the company's 2015 sustainability goals in the area of health,by eliminating more than one billion pounds of trans and saturated fat from the ...
The US Food and Drug Administration(FDA)has granted 510(k)clearance to Ivera Medical's Curos Tips passive disinfection device which covers and protects the male luer connectors. Used in the administration of intravenous(IV)medication ...
Tags: FDA, male luer connectors, IV, Curos Tips
Valensa International has announced that it has received US Food&Drug Administration(FDA)Generally Recognized as Safe(GRAS)status for its Parry Organic Spirulina ingredient. Valensa International claimed that Parry Organic Spirulina is ...
Tags: FDA, Organic Spirulina, safe
HTG Molecular Diagnostics has collaborated with John Wayne Cancer Institute (JWCI) to market its HTG melanoma signature assays. The signature assays may be useful for diagnostic and prognostic applications along the melanoma ...
Tags: HTG melanoma signature assays, clinical technology, clinical research
Meridian Bioscience has received FDA clearance for TRU Legionella, a new rapid assay for detection of legionellosis. TRU Legionella provides optimized detection of Legionella pneumophila serogroup 1 that is most commonly associated ...
Tags: TRU Legionella, detection of legionellosis, clinical research
Medivation and Astellas Pharma have launched Xtandi (enzalutamide) capsules for patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. Xtandi, an oral, once-daily androgen receptor inhibitor ...
Biotechnology company Avaxia Biologics has received AVX-470 investigational new drug (IND) application clearance for the treatment of ulcerative colitis from the FDA. The bovine anti-tumor necrosis factor polyclonal antibody is based on ...
Tags: Avaxia, Ulcerative Colitis Therapy, IND