U.S. Food and Drug Administration finalized a molluscan shellfish equivalence determination for two European Union (EU) Member States, Spain and the Netherlands.
The following is attributed to FDA Commissioner Stephen M. Hahn, M.D., and Patrizia Cavazzoni, M.D., acting director, Center for Drug Evaluation and Research
The U.S. Food and Drug Administration announced that a public meeting of the Vaccines and Related Biological Products Advisory Committee will be held on Oct. 22, 2020, to discuss the general matter of the development, authorization, and/or licensure of vaccines indicated to prevent COVID-19.
The American Society of Pharmacovigilance (ASP) announced that the Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Initiative has developed a collaborative community with participation by the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH).
VAPORESSO issued the following announcement on August 24.On August 20, 2020, VAPORESSO received the acceptance letter for the first round of its PMTA applications from the FDA - only three days after submission.
If approved, Xolair self-administration would offer a more flexible option to help select patients manage their treatment needs
The investment from Koch Disruptive Technologies, Longliv Ventures, a member of the CK Hutchison Holdings and OurCrowd will fuel Sight’s R&D into the automated identification and detection of diseases
PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that the Drug Master File (DMF) that its partner, Austrianova, filed with the U.S. Food and Drug Administration (FDA) has been accepted without any questions or suggested changes.
Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the PLATEAU-A Ti Anterior Lumbar Spacer System.
Device designed to treat below-the-knee vessels from the radial arteries with industry’s longest (250 cm) working length
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless cervical cancer detection test based on its patented biophotonic technology, announced that it had submitted its protocol to FDA for a clinical study to support marketing of the LuViva® Advanced Cervical Scan in the United States.
The U.S. Food and Drug Administration published the proposed rule, Annual Summary Reporting Requirements Under the Right to Try Act, that when finalized, will implement a statutory requirement for sponsors and manufacturers to provide an annual summary to the FDA for any eligible investigational drug they provide to eligible patients under the Right to Try Act.
Latest NeuroBlate System software delivers superior visualization for neurosurgeons
Announce FDA’s New Era of Smarter Food Safety Blueprint.
Subsidiary to Advance Commercial Development of Diagnostic Tests for Virology, COVID-19, Oncology
The U.S. Food and Drug Administration has been thoughtfully and deliberately determining the safest and most appropriate time to resume prioritized domestic inspections of FDA-regulated facilities and other associated activities since we first announced postponement in March.
AI-powered reading aid for screening mammography improves Radiologists' performance in cancer detection