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FDA Accepts SNY and REGN's Dupixent Re-Submitted sBLA for Urticaria

Sanofi SNY and partner Regeneron REGN announced that the FDA has accepted their resubmitted supplemental biologics license application (sBLA) seeking approval of Dupixent for the treatment of chronic spontaneous urticaria (CSU).

GlobalData on MSN · 3d

FDA reviews Sanofi and Regeneron’s Dupixent label expansion for urticaria

The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.

Business Insider · 3d

Sanofi, Regeneron's Dupixent SBLA Accepted For FDA Review To Treat Chronic Spontaneous Urticaria

French drug major Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the U.S. Food and Drug Administration

MarketWatch · 3d

Regeneron, Sanofi Get New FDA Review of Dupixent for CSU

The FDA last year turned away the companies' application and asked for additional efficacy data. Regeneron and Sanofi said the resubmission adds results from an additional Phase 3 study of Dupixent in CSU, which causes sudden and debilitating hives and recurring itch.

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Regeneron Pharmaceuticals (NASDAQ:REGN) Upgraded at Wolfe Research

Wolfe Research upgraded shares of Regeneron Pharmaceuticals (NASDAQ:REGN – Free Report) to a strong-buy rating in a report ...

Unlocking future medicines: The crucial role of clinical trials

Regeneron’s clinical trials are at the core of this mission. Regeneron is grateful to all clinical trial participants — ...

FDA To Revisit Regeneron/Sanofi's Dupixent For Rare Skin Disease

Regeneron and Sanofi's Dupixent sBLA for treating chronic spontaneous urticaria in patients 12+ gets FDA review, with a ...

Yahoo Finance5d

Regeneron/Sanofi's Dupixent Approval Signals Major Treatment Breakthrough For Smokers' Lung Disease

Also Read: Regeneron’s Dupixent COPD Sales To Reach $20B By 2026, Analyst Sees Larger Addressable Market The condition ...

3don MSN

Final Trades: Berkshire Hathaway, Regeneron, DocuSign and Leidos Holdings

Dallas salon owner Shelley Luther discusses her comeback after being jailed for keeping her small business open during COVID ...

Wolfe Research starts Regeneron at Outperform, sees ‘attractive entry point’

Wolfe Research initiated coverage of Regeneron (REGN) with an Outperform rating and $1,150 price target Eylea patent litigation concerns had ...

2 Top Growth Stocks to Buy on the Dip

Has something changed regarding Eli Lilly or Regeneron's thesis, or is the recent dip an excellent opportunity to invest in ...

Yahoo Finance7d

Regeneron Announces Investor Conference Presentations

The sessions may be accessed from the "Investors & Media" page of Regeneron's website at https://investor.regeneron.com/events-and-presentations. Replays and ...

Check Out What Whales Are Doing With REGN

Looking at options history for Regeneron Pharmaceuticals REGN we detected 8 trades. If we consider the specifics of each ...

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