• Disclosure
  • Privacy Policy
  • DMCA Policy
  • CCPA
  • Medical Disclaimer
Friday, January 27, 2023
Smith County News Online
  • Home
  • News
  • Business
  • Technology
    • Crytpocurrency
    • Gaming
    • Gadgets
  • Sports
  • Health
  • General
    • Business Services
  • Travel
  • Press Releases
  • Popular
No Result
View All Result
  • Home
  • News
  • Business
  • Technology
    • Crytpocurrency
    • Gaming
    • Gadgets
  • Sports
  • Health
  • General
    • Business Services
  • Travel
  • Press Releases
  • Popular
No Result
View All Result
No Result
View All Result
Home News

U.S. FDA Delays Decision On Regeneron/Roche COVID Antibody Therapy – Reuters

by NewsReporter
April 14, 2022
in News
us.-fda-delays-decision-on-regeneron/roche-covid-antibody-therapy-–-reuters
Share on FacebookShare on Twitter

The Regeneron Pharmaceuticals company logo is seen on a building at the company’s Westchester campus in Tarrytown, New York, U.S. September 17, 2020. REUTERS/Brendan McDermid

Register now for FREE unlimited access to Reuters.com

April 14 (Reuters) – The U.S. Food and Drug Administration has extended by three months its review of Regeneron Pharmaceuticals Inc’s (REGN.O) application for the full approval of its COVID-19 antibody therapy, the U.S. drugmaker said on Thursday.

Before making its decision, the health agency wants to look at additional data submitted by Regeneron on using the antibody cocktail as a preventive treatment.

The FDA has not asked for any extra studies to complete its review and will now decide on the drug by July 13, Regeneron said.

Register now for FREE unlimited access to Reuters.com

Regeneron’s “cocktail” of two monoclonal antibodies, casirivimab and imdevimab, had received an emergency use authorization in the United States in late 2020 to treat patients who were 12 years and older with mild-to-moderate COVID-19.

The therapy, called REGEN-COV, was later also authorized in the country for the prevention of COVID-19 in certain people exposed to an infected individual, or who were at high risk of such exposure.

However, data showed that REGEN-COV and a rival monoclonal antibody drug from Eli Lilly (LLY.N) were unlikely to be effective against the highly contagious Omicron coronavirus variant. That led the U.S. FDA to revise the emergency use authorizations for both therapies to limit their use. read more

Regeneron is collaborating with Roche (ROG.S), which is primarily responsible for the development and distribution of the treatment outside the United States.

Register now for FREE unlimited access to Reuters.com

Reporting by Amruta Khandekar and Mrinalika Roy in Bengaluru; Editing by Maju Samuel and Devika Syamnath

Our Standards: The Thomson Reuters Trust Principles.

Related Posts

‘god’s-going-to-help-us-get-through-all-of-this.’-a-165-mph-tornado-causes-widespread-devastation-in-texas-community-–-cnn

‘God’s Going To Help Us Get Through All Of This.’ A 165 Mph Tornado Causes Widespread Devastation In Texas Community – CNN

by NewsReporter
April 15, 2022
0

(CNN)After a tornado packing 165 mph winds rolled through Bell County, Texas, Tuesday, JudyLynn Hughes began sifting through what was left of her belongings."We have found my stuff everywhere. I still have a dress in a tree," Hughes told CNN affiliate KWTX.Nearly everything she owned was packed up in storage...

tarleton-state-to-sell-beer,-wine-at-spring-football-game-–-stephenville-empire-tribune

Tarleton State To Sell Beer, Wine At Spring Football Game – Stephenville Empire-Tribune

by NewsReporter
April 14, 2022
0

TSU Newsroom  |  Stephenville Empire-TribuneSTEPHENVILLE — As a trial run to enhance its Texan fan experience, Tarleton State University will sale beer and wine at its spring football game April 23 at Memorial Stadium. The Texas Alcoholic Beverage Commission issued a one-day permit.If the university receives a full two-year TABC...

ronnie-forbes-|-obituaries-–-the-daily-courier

Ronnie Forbes | Obituaries – The Daily Courier

by NewsReporter
April 14, 2022
0

Ronald “Ronnie” Charles Forbes, 52, of Charlotte, passed away April 12, 2022 at his home. He was born February 18, 1970 in Cleveland County, North Carolina, a son of Jack Forbes and the late Sandra Martin Forbes.Ronnie graduated from East Rutherford High School in 1988 and attended Central Piedmont Community...

us.-weighs-sending-top-level-official-to-meet-zelenskyy-in-kyiv-–-politico

U.S. Weighs Sending Top-Level Official To Meet Zelenskyy In Kyiv – POLITICO

by NewsReporter
April 13, 2022
0

Ukrainian President Volodymyr Zelenskyy speaks alongside the presidents of Poland, Lithuania, Latvia and Estonia during a press conference in Kyiv on April 13. | Adam Schreck/AP Photo The Biden administration is holding internal discussions about sending a high-level official to Kyiv to show further support to Ukraine, two U.S. officials...

Smith County News Online

© 2021 Smith County News Online

Navigate Site

  • Disclosure
  • Privacy Policy
  • DMCA Policy
  • CCPA
  • Medical Disclaimer

Follow Us

No Result
View All Result
  • Home
  • DMCA Policy
  • Medical Disclaimer
  • Privacy Policy
  • Disclosure
  • CCPA
  • Terms of Use

© 2021 Smith County News Online

We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept All”, you consent to the use of ALL the cookies. However, you may visit "Cookie Settings" to provide a controlled consent.
Cookie SettingsAccept All
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
SAVE & ACCEPT