AACC: Not All FDA-Authorized COVID-19 Antibody Tests Are Equally Reliable
Crucial findings published in AACC's Clinical Chemistry journal
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Q30 INNOVATIONS: Requests FDA Authorization for Q-Collar Device Designed to Aid in the Protection of the Brain from the Effects of Head Impacts in Contact Sports
After eight years of scientific research and clinical trials, Q30 Innovations announced that it has submitted a request for De Novo classification to the U.S. Food and Drug Administration, seeking authorization to market the Q-Collar in the United States.
THERANICA: Expands Executive Team Amid Growing US Demand for Its FDA-authorized Migraine Treatment Wearable Device
During Initial Limited Commercial Launch, Nerivio® Was Used more than 30,000 Times to Address Migraine Pain and other Symptoms
EVERLYWELL: COVID-19 Test Home Collection Kit receives first FDA Emergency Use Authorization of its kind
Everlywell's FDA-authorized home collection kit for COVID-19 will be available for individuals and organizations later this month
THERMEDICAL: Thermedical’s Groundbreaking SERF Ablation System Earns FDA’s Breakthrough Device Designation
Thermedical®, a developer of thermal-ablation medical systems to treat ventricular tachycardia (VT), today announced that it has received Breakthrough Device Designation from the U.S. Food & Drug Administration (FDA) for its Saline Enhanced Radiofrequency (SERF) Ablation system and Durablate® catheter.
FDA: Coronavirus (COVID-19) Update: FDA Collaborations Promote Rigorous Analyses of Real-World Data to Inform Pandemic Response
We are announcing another step in our effort to harness diverse streams of data to understand and respond to COVID-19. The U.S. Food and Drug Administration has entered into an agreement with Aetion to collaborate on advanced analytical techniques to answer urgent coronavirus disease (COVID-19) research questions.
FDA: Feed Your Mind with FDA's New Education Initiative on Genetically Engineered Foods
The U.S. Food and Drug Administration (FDA), with the U.S. Department of Agriculture (USDA) and U.S. Environmental Protection Agency (EPA), launched Feed Your Mind, a new Agricultural Biotechnology Education and Outreach Initiative. The Initiative aims to increase consumer awareness and understanding of genetically engineered foods or GMOs.
MARENA: Georgia-Based Healthcare Manufacturer, Marena, to Supply Poll Workers With FDA-Approved Face Masks Ahead of June Primary
The Marena Group LLC, a Georgia-based medical device manufacturer, announced that they will be supplying Georgia election and poll officers with 35,000 masks for protection against COVID-19.
FDA: Releases Report on Investigation into Fall 2019 Outbreaks of Illnesses Tied to Romaine Lettuce
As the nation grapples with the COVID-19 public health emergency, the U.S. Food and Drug Administration is grateful for all that the food and agricultural sector is doing to provide safe and available food to consumers during this difficult time.
LGMA: Leafy Greens Marketing Agreement to Use Clues from FDA Report to Prevent Future Outbreaks
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.
HIKMA: Receives FDA approval for its generic Vascepa®
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®.
EVOFEM BIOSCIENCES: U.S. FDA Approves Evofem Biosciences' Phexxi™ (lactic acid, citric acid and potassium bitartrate), the First and Only Non-Hormonal Prescription Gel for the Prevention of Pregnancy
A New Class of Female-Controlled Birth Control for Use In-The-Moment
SMART MEDICAL SYSTEMS: Receives FDA Clearance for Its G-EYE® Colonoscope
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
ORTEQ® SPORTS MEDICINE: Announces Publication of 5-year Multi- Center Clinical Data for the Actifit® Meniscal Scaffold in the American Journal of Sports Medicine (AJSM), Receives FDA Breakthrough Device Designation
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.
EXPRESSION THERAPEUTICS: Announces IND Approval by the FDA for Hemophilia A Gene Therapy
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.
FDA: Coronavirus (COVID-19) Update: FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection
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.
PROTALIX BIOTHERAPEUTICS: Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Submission of Biologics License Application to U.S. Food and Drug Administration for Pegunigalsidase Alfa for the Treatment of Fabry Disease
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.
QUEST DIAGNOSTICS: FDA Authorizes Quest Diagnostics COVID-19 Nasal Specimen Self-Collection Kit for Emergency Use
Company to make the device available through broad range of healthcare, state, employer and consumer-initiated channels
FDA: Alerts Patients and Health Care Professionals to Nitrosamine Impurity Findings in Certain Metformin Extended-Release Products
Agency Continues Investigations of Nitrosamine Impurities in Drug Products
FDA: Coronavirus (COVID-19) Update: FDA Takes Steps to Streamline Development of Tests With At-Home Sample Collection
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.