Health News

Companies Seek EUA for New COVID Monoclonal Antibody Treatment

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. An independent data monitoring committee is recommending stopping enrollment of a phase 3 trial of a monoclonal antibody for COVID-19 because interim results indicate an 85% (P = .002) reduction in hospitalizations or death, two companies have announced. Vir Biotechnology and […]

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Why Are Vaccines Still in Short Supply?

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Boxes containing the Pfizer-BioNTech covid-19 vaccine are prepared to be shipped at the Pfizer Global Supply Kalamazoo manufacturing plant. The U.S. government has invested billions of dollars in manufacturing, used a wartime act dozens of times to boost supplies and yet […]

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Trials of retooled vaccines for variants could take months: U.S. FDA

(Reuters) – Drugmakers should test any COVID-19 vaccines that have been retooled to combat new variants of the coronavirus in clinical trials designed to track the immune response of hundreds of test subjects, which could take months, U.S. regulators said on Monday.Slideshow ( 3 images )Vaccine developers may need to modify their shots to provide […]

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FDA Review Finds Pfizer COVID-19 Vaccine Effective After First Dose

TUESDAY, Dec. 8, 2020 — New data released Tuesday by the U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee suggest that Pfizer’s two-dose COVID-19 vaccine works well protecting recipients against COVID-19. The committee is scheduled to meet on Thursday to consider the Pfizer/BioNTech COVID-19 vaccine for emergency use authorization, CNBC reported. […]

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Any mask containing metal could cause burns during an MRI, FDA warns

(HealthDay)—Patients who wear face masks with metal parts or coatings during MRIs could suffer facial burns, the U.S. Food and Drug Administration warned Monday. That’s because metal parts such as bendable nose clips or wires, staples on the headband, nanoparticles (ultrafine particles), or antimicrobial coating that may contain metal (such as silver or copper) can […]

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Coronavirus face masks can be reused with 'dry heat,' FDA says

Getting coronavirus vaccine will help protect the community: Dr. Siegel Dr. Marc Siegel says the vaccine may be ‘uncomfortable’ at first but will keep people safer and healthier in the long run. While the U.S. Food and Drug Administration (FDA) says health care workers should ideally use new personal protective equipment amid the coronavirus pandemic, strained supplies have caused […]

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FDA Authorizes Use of Monoclonal Antibody Treatment for COVID-19

MONDAY, Nov. 23, 2020 — A combination of two monoclonal antibodies was granted emergency use authorization (EUA) for the treatment of mild-to-moderate COVID-19, the U.S. Food and Drug Administration announced Saturday. The combination of casirivimab and imdevimab, which must be administered together by intravenous infusion, is approved for use in treating patients ages 12 years […]

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FDA issues EUA to baricitinib plus remdesivir for COVID-19

(HealthDay)—Emergency use authorization was issued for baricitinib in combination with remdesivir for hospitalized patients with COVID-19, the U.S. Food and Drug Administration announced Thursday. The EUA for the combination treatment applies to hospitalized patients ages 2 years and older with suspected or laboratory-confirmed COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. […]