Categories Food and Drug Administration

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Ro makes the weight loss product Plenity commercially available to everyone in the U.S.

In what could be the first step in the development of a significant new line of business for the telemedicine prescription provider Ro, the company is finally announcing the general commercial availability of weight loss product, Plenity. Developed by Gelesis, a biotech company that makes treatments for gastro-intestinal disorders, Plentiy […]

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FDA revokes emergency authorization for chloroquine and hydroxychloroquine in COVID-19 treatment

The U.S. Food and Drug Administration (FDA) has revoked an emergency use authorization (EUA) that it previously issued for chloroquine and hydroxychloroquine, two anti-malarial drugs also used in the treatment of chronic rheumatoid arthritis (via The Washington Post). These are the drugs that President Trump famously touted as effective in […]

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Cue Health’s portable, fast COVID-19 test gains FDA emergency approval

Fresh off a $100 million Series C funding round, molecular diagnostics startup Cue Health has more good news — it has received an Emergency Use Authorization (EUA) for its rapid, point-of-care COVID-19 test. The company got a $13 million grant from BARDA in March to help it scale its development […]

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FDA authorizes a ventilator developed by NASA’s JPL for emergency use in COVID-19 treatment

The U.S. Food and Drug Administration (FDA) has authorized for emergency use as outlined in the agency’s COVID-19 guidelines a new ventilator designed by engineers working at NASA’s Jet Propulsion Laboratory . The ventilator, which has an acronym because this is NASA we’re talking about, is called “VITAL” (Ventilator Intervention […]

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FDA reiterates risks of antimalarial drug use for COVID-19, as study into efficacy ends early due to deaths

The U.S. Food and Drug Administration (FDA) has issued a new warning about the known side effects of hydroxychloroquine and chloroquine, two antimalarial drugs (also used in the treatment of chronic rheumatoid arthritis and lupus), on the same day that a group of researchers published a paper in the Journal […]

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Curative received FDA emergency use authorization for its novel COVID-19 tests

The diagnostics startup Curative has received an emergency use authorization from the Food and Drug Administration for its novel test to determine COVID-19 infection. The company says that its tests have already been used by the City of Los Angeles since late March and have tested over 53,000 city residents. […]

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FDA introduces a new program to expedite deployment of potential coronavirus treatments

The U.S. Food and Drug Administration (FDA) announced a new program today that’s designed to foster close collaboration between public and private organizations in order to “bring coronavirus treatments to market as fast as possible,” according to U.S. Department of Health & Human Services Secretary Alex Azar in a press […]

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A new FDA-authorized COVID-19 test doesn’t need a lab and can produce results in just 5 minutes

There’s a new COVID-19 test from healthcare technology maker Abbott that looks to be the fastest yet in terms of producing results, and that can do so on the spot right at point-of-care, without requiring a round trip to a lab. This test for the novel coronavirus causing the current […]

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How one company is fast-tracking development of potential plasma-based treatments for the coronavirus

Medical biotech company Emergent BioSolutions is one of the many health industry players turning its efforts toward addressing the current global coronavirus pandemic. Their work includes a two-pronged effort to pursue plasma-based treatments that could help lessen the impact of COVID-19 on healthcare systems, with a fast-tracked development timeline that […]

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FDA updates COVID-19 testing guidelines to allow self-swab tests

The FDA has updated its guidelines for COVID-19 testing procedures to make the process easier and less uncomfortable for patients, as well as to help limit the impact of testing on the supply of personal protective equipment (PPE) used by healthcare workers, including protective masks, face shields, gloves and gowns. […]