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COVID-19 News (Page 16)
Related terms: 2019-nCoV, 2019 Novel Coronavirus, Coronavirus, SARS-CoV-2 Infection, Novel Coronavirus Pneumonia
FDA Approves Veklury (remdesivir) to Treat COVID-19 in People With Mild to Severe Hepatic Impairment With no Dose Adjustment
FOSTER CITY, Calif.--(BUSINESS WIRE) August 24, 2023 – Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug...
FDA Approves Veklury (remdesivir) for COVID-19 Treatment in Patients With Severe Renal Impairment, Including Those on Dialysis
FOSTER CITY, Calif.--(BUSINESS WIRE) July 14, 2023 – Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug...
Janssen COVID-19 Vaccine No Longer Authorized for Emergency Use
On Thursday June 1, 2023, the FDA revoked the emergency use authorization (EUA) of the Janssen COVID-19 Vaccine. On May 22, 2023, Janssen Biotech Inc. requested the voluntary withdrawal of the EUA ...
FDA Approves Paxlovid (nirmatrelvir tablets and ritonavir tablets) for Adult Patients at High Risk of Progression to Severe COVID-19
NEW YORK--(BUSINESS WIRE) May 25, 2023 – Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) approved Paxlovid™ (nirmatrelvir tablets and ritonavir tablets) for t...
Update on US Food and Drug Administration Emergency Use Authorisation of Evusheld
26 January 2023 – The US Food and Drug Administration (FDA) has stated that AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) is not currently authorised for Emergency Use for p...
FDA Approves Genentech’s Actemra for the Treatment of COVID-19 in Hospitalized Adults
South San Francisco, CA – December 21, 2022 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has a...
FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region
November 30, 2022 – The U.S. Food and Drug Administration today announced bebtelovimab is not currently authorized for emergency use in the U.S. because it is not expected to neutralize Omicron...
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...