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COVID-19 News (Page 16)
Related terms: 2019-nCoV, 2019 Novel Coronavirus, Coronavirus, SARS-CoV-2 Infection, Novel Coronavirus Pneumonia
Pfizer and BioNTech Announce U.S. FDA Approval of Their COVID-19 Vaccine Comirnaty for Adolescents 12 Through 15 Years of Age
Comirnaty® is the first and only COVID-19 vaccine to be granted FDA approval for adolescents 12 years and older, following emergency use authorization in May 2021 Approval of the two-dose primary ...
FDA Approves Olumiant (baricitinib) Treatment for COVID-19 in Certain Hospitalized Adults
Olumiant is the first and only JAK inhibitor FDA-approved for the treatment of COVID-19 in certain hospitalized adults requiring various degrees of oxygen support INDIANAPOLIS, May 11, 2022...
Veklury (remdesivir) is First and Only Approved Treatment for Pediatric Patients Under 12 Years of Age with COVID-19
Approval is Supported by Phase 2/3 Data Demonstrating the Safety and Tolerability Profile and Clinical Improvement Outcome in Hospitalized Pediatric Patients Treated with Veklury FOSTER CITY,...
Lilly's Bebtelovimab Receives Emergency Use Authorization for the Treatment of Mild-to-Moderate COVID-19
INDIANAPOLIS, Feb. 11, 2022 /PRNewswire/ – The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bebtelovimab, an antibody that demonstrates neutralization...
Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine Spikevax
Approval based on a comprehensive submission package including efficacy and safety data approximately six months after second dose Spikevax has received approval by regulators in more than 70...
FDA Approves Veklury (remdesivir) for the Treatment of Non-Hospitalized Patients at High Risk for COVID-19 Disease Progression
Approval Based on Phase 3 Data Showing Veklury Significantly Reduced Risk of Hospitalization By 87% Compared with Placebo NIH Guidelines Recommend Veklury for the Treatment of Non-Hospitalized...
Evusheld (formerly AZD7442) Long-Acting Antibody Combination Authorised for Emergency Use in the US for Pre-Exposure Prophylaxis (Prevention) of COVID-19
Only antibody therapy authorised in US for pre-exposure prophylaxis Pivotal phase III data showed robust efficacy and long-term protection with one dose in high-risk population AstraZeneca's...
FDA Approves Comirnaty (Pfizer-BioNTech COVID-19 Vaccine) to Prevent COVID-19 Individuals 16 Years and Older
Comirnaty is the first COVID-19 vaccine to be granted FDA approval Approval is based on a comprehensive submission package including six-month efficacy and safety data after second dose More than...
Genentech’s Actemra Receives FDA Emergency Use Authorization for the Treatment of COVID-19 In Hospitalized Adults and Children
South San Francisco, CA – June 24, 2021 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has issued an...
High Vitamin D Levels May Help Prevent COVID-19, Especially in Black Patients
FRIDAY, March 19, 2021 – Vitamin D – better known as the "sunshine vitamin" – might protect you from COVID-19, a new study suggests. Researchers said that the protection is particularly potent...
Obesity a Big Risk Factor for Severe COVID-19, Study Confirms
MONDAY, March 8, 2021 – Yet another study confirms what doctors have long known: Being obese greatly raises the odds that if you contract COVID-19, your case could be a severe one. The study, from...
FDA Approves Veklury (remdesivir) for the Treatment of COVID-19
FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 22, 2020-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved the antiviral drug Veklury...
FDA Medwatch Alert: Remdesivir by Gilead Sciences: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of Treatment
ISSUE: FDA is warning health care providers that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral...
Much Needed Rapid Diagnostic Test, Xpert Xpress SARS-CoV-2, Authorized
Emergency Use Authorization (EUA) has been granted by the Food and Drug Administration (FDA) for California-based Cepheid’s, Xpert Xpress SARS-CoV-2 test. This is the first coronavirus test that can b...
Gilead Halts Remdesivir Access for COVID-19 Amid Other U.S. Drug Shortages
Gilead Halts Remdesivir Access for COVID-19 Amid Other U.S. Drug Shortages March 23, 2020 - Leigh Ann Anderson, PharmD In a jarring headline on Sunday, Gilead Sciences Inc. announced a temporary...