U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible
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Drugs Pose Significant Risks to Patient Health and Violate Federal Law
Diagnostic tests are an important tool in anticipating and meeting the continuing and evolving public health needs as we combat COVID-19.
The durable, reliable, and low-cost ventilator is ideal for COVID-19 use in hospitals throughout the world.
Naviswiss AG, a medical technology company based in Denver, Colorado, with headquarters in Brugg, Switzerland, receives FDA Clearance on June 10, 2020, for their new navigation technology for hip replacement surgery.
Respira announces plans to pursue FDA authorization of the RespiRxTM drug delivery platform as the first vapor style inhalable Nicotine Replacement Therapy (NRT) designed to significantly increase cessation therapy effectiveness in the U.S.
Frozen Wheels, a leading distributor of food and PPE, is announcing the opening of an office in Thailand in response to the growing demand for powder-free nitrile examination gloves.
TSS is ready to decontaminate masks immediately.
U.S. Food and Drug Administration has taken an additional step in harnessing real-world data to help inform the agency’s overall response to the COVID-19 public health emergency.
CLEWICU is the only device authorized by the FDA to provide early identification of patients who are likely to experience respiratory failure or hemodynamic instability, both potentially common but significant complications associated with COVID-19
U.S. Food and Drug Administration has taken an additional step in harnessing real-world data to help inform the agency’s overall response to the COVID-19 public health emergency.
Medakit Ltd, a leading biotech company specialized in the production of antibody diagnosis tests for COVID-19, received on June 10th a warning letter from the Food and Drug Administration outlining their concern regarding the terminology utilized in Medakit website allegedly suggesting the use of Medakit test for "home-use" settings.
U.S. Secretary of Agriculture Sonny Perdue and FDA Commissioner Stephen M. Hahn, M.D., issued the following statement regarding food export restrictions pertaining to COVID-19
Allergan, an AbbVie Company (NYSE: ABBV), and Molecular Partners (SIX: MOLN), a clinical-stage biotechnology company developing a new class of custom-built protein therapeutics known as DARPin® therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter to the Biologics License Application (BLA) for Abicipar pegol, a novel, investigational DARPin® therapy for patients with neovascular (wet) age-related macular degeneration (nAMD).
Since the sudden onset of the COVID-19 pandemic the United States has faced a supply constraint of quality N95 masks.
Enhanced performance and high throughput screening up to 384 samples simultaneously
The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for a rapid COVID-19 antibody test distributed by Virality Diagnostics LLC, manufactured by Biohit (Hefei).
Companion Medical, manufacturers of InPen, the only FDA-cleared smart insulin pen system, announced that they received FDA expanded clearance for all ages* to use the InPen System.
Circadia Health announced today that it has received expedited FDA clearance for Contactless Respiration Rate (CResp®) monitoring due to COVID-19.
Bioventus, a global leader in orthobiologic solutions, is launching its SIGNAFUSE Bioactive Bone Graft in a new strip format.