Saturday, November 21, 2020

A news list of treatments on humans approved recently by FDA as at 21 November 2020


 News (1), (2)

FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19

---> Monoclonal antibodies casirivimab and imdevimab are approved for covid treatment on 21 November 2020. They must be administered together with intravenous (IV) infection. They are not authorized for hospitalized covid patients or covid patients that require oxygen therapy.

On 9 November 2020, FDA authorizes the monoclonal antibody bamlanivimab for covid treatment. This is the first monoclonal antibody to be approved.

Ref: FDA Authorizes Monoclonal Antibody Treatment for COVID-19https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibody-treatment-covid-19

News (3)

FDA Approves First Treatment for Hutchinson Gilford Progeria Syndrome and Some Properoid Laminopathies, https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-hutchinson-gilford-progeria-syndrome-and-some-progeroid-laminopathies

---> Zokinvy (lonafamib) capsules are approved on 20 November 2020 for babies and children less than 15 years old suffering from rare genetic disease Hutchinson Goilford properia syndrome and some properoid laminopathies.


News (4)

FDA Authorizes First COVID-19 Test for Self-Testing At Home, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-test-self-testing-home

---> The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test is authorized on 17 November 2020.


News (5)

FDA Authorizes First Test That Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-test-detects-neutralizing-antibodies-recent-or

---> The cPass SARS-CoV-2 Neutralization Antibody Detection Kit is authorized on 6 November 2020.


News (6)

FDA Approves First Treatment for COVID-19https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19

---> Remdesivir is approved on 22 October 2020.

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