The National Cannabis Industry Association (NCIA) says the Federal Drug Administration (FDA) should take immediate steps to approve non-psychoactive cannabidiol components such as CBD for general use.
The first World Food Safety Day was held on June 7 with deputy commissioner for food policy and response Frank Yiannas representing the Food and Drug Administration.
A new pilot program, Project Facilitate, was announced last week by the Food and Drug Administration to help oncology health-care professionals access unapproved therapies for their cancer patients.
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CorMatrix® Cardiovascular, Inc. www.cormatrix.com, a leading developer of regenerative cardiovascular medical devices, announced FDA 510(k) clearance for the Cor™ PATCH. The Cor™ PATCH is indicated for epicardial tissue support and repair in adult patients.
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MetVital, Inc., a biopharmaceutical company developing small molecule modulators of glutamate metabolism for the treatment of diseases with significant unmet medical need and commercial potential, announces that the U.S. Food and Drug Administration (FDA) has notified MetVital that it may proceed with its clinical investigation of "Anhydrous Enol-Oxaloacetate" (AEO) as a potential treatment for patients with Glioblastoma Multiforme.
Some believe with the advent of gene therapy, the future of medicine has been seen.
Emerging biotech companies developed nearly two-thirds of the new drug therapies approved last year in the United States, according to a new study by the pharmaceutical research company Iqvia.
EmCyte, is proud to announce that it has received FDA 510(k) clearance for its PureBMC® Supraphysiologic Concentrating System.
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Commercial availability of NOCITA 10 mL vial size anticipated by fall 2019
The FDA pilot program explores innovative and emerging approaches for the tracing and verification of prescription products
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TriNetX, the global health research network that revolutionizes clinical research and enables discoveries through the generation of real-world evidence (RWE), praised the House Appropriations Committee for approving its fiscal year 2020 Agriculture, Rural Development, FDA, and Related Agencies bill which includes support for the use of RWE in regulatory decision making.
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Jared Wheat, CEO of Hi-Tech Pharmaceuticals, released the following statement in response to the return over $19 million worth of DMAA to Hi-Tech Pharmaceuticals
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Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, today announced the U.S. Food and Drug Administration's (FDA) approval of the new Cochlear™Nucleus® Profile™ Plus Series Cochlear Implant and the Nucleus 7 Sound Processor's new built-in connectivity featuring direct streaming with compatible Android™ smartphones.
Bio-Techne announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its ExoDx Prostate IntelliScore (EPI) test, making it the first exosome-based liquid biopsy test to receive a Breakthrough Device Designation.
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Three years ago, the U.S. Food and Drug Administration announced the most comprehensive reform to the Nutrition Facts label since its introduction in 1993
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On June 13, 2019, the U.S. Food and Drug Administration (FDA) issued a safety alert regarding the use of fecal microbiota for transplantation, or FMT
WASHINGTON, D.C. -- A physician has applauded a new FDA program that aims to simplify the process doctors use to offer non-approved cancer treatments to patients.
CARsgen Therapeutics, a clinical-stage company committed to developing Chimeric Antigen Receptor T cell therapies for cancer, announced that one of its leading drug candidates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treatment of patients suffering from relapsed/refractory multiple myeloma (rrMM), has received Investigational New Drug (IND) clearance from the United States Food and Drug Administration (FDA).
The U.S. Food and Drug Administration is committed to helping facilitate American patients’ access to lower-cost generic medicines by taking steps to enhance and streamline the development and approval process of high-quality generic drugs.
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