FDA authorizes REGEN-COV mAb for prevention for COVID-19
The U.S. Food and Drug Administration today revised the emergency use authorization (EUA) for REGEN-COV (casirivimab and imdevimab, administered together) authorizing REGEN-COV for emergency use...
FDA Expands Authorized Use of REGEN-COV™ (casirivimab and …
Jul 30, 2021 · Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) updated the Emergency Use Authorization (EUA) for the investigational COVID-19 antibody cocktail REGEN-COV™ (casirivimab and imdevimab).
Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal …
Today, the FDA issued an emergency use authorization for two monoclonal antibodies to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients who...
Regeneron Provides Update on Biologics License Application for ...
Mar 25, 2024 · Regeneron is committed to working closely with the FDA and investigators to bring odronextamab to patients with R/R FL and R/R DLBCL as quickly as possible. Regeneron plans on sharing updates on enrollment and regulatory timelines later this year.
FDA To Revisit Regeneron/Sanofi's Dupixent For Rare Skin Disease
2 days ago · On Friday, the FDA accepted for review the resubmission of the supplemental biologics license application (sBLA) for Regeneron Pharmaceuticals, Inc. REGN and Sanofi SA’s SNY Dupixent (dupilumab ...
US FDA declines to approve Regeneron's higher-dose Eylea, …
Jun 28, 2023 · U.S. health regulators on Tuesday declined to approve a higher-dose version of Regeneron Pharmaceuticals' drug Eylea for treatment of a disease that is leading cause of blindness among the...
FDA authorizes Covid antibody treatment as preventive after ... - NBC News
With the FDA's expanded authorization, Regeneron’s antibody cocktail can be given as an injection. The first dose needs to be administered within 96 hours of exposure.
News Release - Regeneron Pharmaceuticals Inc.
TARRYTOWN, N.Y., April 14, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has extended by three months its review of the Biologics License Application (BLA) for REGEN-COV ® (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as ...
FDA okays Regeneron COVID-19 antibody as preventive in high …
Jul 30, 2021 · The U.S. Food and Drug Administration has expanded the emergency use authorization of Regeneron Pharmaceuticals Inc's (REGN.O) COVID-19 antibody cocktail, enabling its use as a preventive...
Kevzara® (sarilumab) Approved by FDA as First and Only Biologic ...
Mar 1, 2023 · TARRYTOWN, N.Y. and CAMBRIDGE, Mass., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Kevzara ® (sarilumab) for the treatment of polymyalgia rheumatica (PMR), an inflammatory rheumatic disease, in adult patients who have ...