Create Account
Log In
Dark
chart
exchange
Premium
Terminal
Screener
Stocks
Crypto
Forex
Trends
Depth
Close
Check out our Dark Pool Levels


Roche (RHHBY) said Tuesday that it has received an approval from the U.S. Food and Drug Administration for its supplemental Biologics License Application of Xolair or omalizumab prefilled syringe for self-injection across all approved U.S. indications.


RTTNews | Apr 13, 2021 01:42AM EDT

01:41 Tuesday, April 13, 2021 (RTTNews.com) - Roche (RHHBY) said Tuesday that it has received an approval from the U.S. Food and Drug Administration for its supplemental Biologics License Application of Xolair or omalizumab prefilled syringe for self-injection across all approved U.S. indications.

Xolair is the FDA-approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria and nasal polyps.

The company noted that appropriate patients will now have the flexibility to administer Xolair from home, which is particularly important for those who are considered high-risk during the COVID-19 pandemic.

Xolair, which was first approved in the U.S. in 2003 to treat allergic asthma and is now also approved for chronic idiopathic urticaria and nasal polyps, previously required a healthcare professional administration.

In the U.S., Roche's Genentech and Novartis work together to develop and co-promote Xolair.

Read the original article on RTTNews ( https://www.rttnews.com/3184321/fda-approves-roche-s-xolair-prefilled-syringe-for-self-injection-across-all-indications.aspx)

For comments and feedback: contact editorial@rttnews.com

Copyright(c) 2021 RTTNews.com All Rights Reserved






Share
About
Pricing
Policies
Markets
API
Info
tz UTC-5
Connect with us
ChartExchange Email
ChartExchange on Discord
ChartExchange on X
ChartExchange on Reddit
ChartExchange on GitHub
ChartExchange on YouTube
© 2020 - 2026 ChartExchange LLC