The New 10 minute Antibody Test from Access Medical Labs sets a new standard after the CDC announced antibody testing may be wrong 50% of the time
Marks 8th FDA clearance for BlueStar, the only reimbursable software as a medical device for diabetes that integrates with all of a patient's existing devices
New metal-alloy sheath converts angioplasty balloons into scoring and cutting systems
Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, located in Hyderabad India, recently received FDA approval for their generic versions of Oseltamivir Phosphate Capsules and Dofetilide Capsules.
Leading Provider to National Pharmaceutical and Long-Term Care Industries Has 3-Ply Surgical and KN95 Masks In Stock, Ready to Ship Same Day.
U.S. Food and Drug Administration publicly posted test performance data from four more antibody, or serology, test kits on open.fda.gov from its independent performance validation study effort with the National Institutes of Health’s (NIH) National Cancer Institute (NCI)
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A federal judge has ordered two individuals doing business as Sundial Herbal Products to stop distributing unapproved new drugs and misbranded drugs until they comply with federal law.
Tecentriq in combination with Avastin is the first and only cancer immunotherapy regimen approved for the treatment of unresectable or metastatic hepatocellular carcinoma
FDA EUA-authorized at-home Coronavirus test is now available in the United States, offering unparalleled safety and scale for consumers
The U.S. Food and Drug Administration took steps to further support the development of COVID-19 tests for at-home self-collection by including a voluntary EUA template for at-home sample collection kits to its website.
Agency Continues Investigations of Nitrosamine Impurities in Drug Products
Company to make the device available through broad range of healthcare, state, employer and consumer-initiated channels
Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, or the Company, together with its development and commercialization partner Chiesi Global Rare Diseases, a unit of Chiesi, an international research-focused healthcare group, today announced the submission on May 27, 2020 of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease via the FDA's Accelerated Approval pathway.
The U.S. Food and Drug Administration took a new step to support the agency’s evaluation of diagnostic tests for COVID-19, by providing a SARS-CoV-2 reference panel.
Expression Therapeutics has announced that it has received clearance by the United States Food and Drug Administration (FDA) to proceed following review of its Investigational New Drug Application (IND) for clinical testing of its novel lentiviral vector-based gene therapy — ET3 — for hemophilia A.
Orteq Sports Medicine Ltd. (www.orteq.com), a developer of joint preservation solutions for orthopedic patients, announces 5-year, multi center, peer-reviewed data published in the AJSM analyzing the Actifit meniscal scaffold that shows more than 87% survival rates with increased knee function and reduced pain.
SMART's G-EYE® Colonoscope, incorporating the G-EYE® Balloon Technology which helps control the endoscope's field of view and positioning during colonoscopy, was cleared for marketing in the USA by FDA
A New Class of Female-Controlled Birth Control for Use In-The-Moment
Hikma Pharmaceuticals PLC (Hikma), the multinational generic pharmaceutical company, today announces that its wholly owned U.S. subsidiary Hikma Pharmaceuticals USA Inc. has received approval from the US Food and Drug Administration (FDA) for its Icosapent Ethyl Capsules, 1 gm, the generic equivalent to Vascepa®.
California leafy greens growers are pledging to incorporate findings from a report issued today by the U.S. Food and Drug Administration (FDA) into its ongoing process to strengthen required food safety practices on farms.