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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.
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 decision expected by April 2025.
Regeneron, Sanofi announce FDA accepts Dupixent sBLA for review
Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License
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.
Seeking Alpha
2d
Sanofi: Diverse Drug Portfolio And Future Pipeline, 4% Dividend Yield Looks Attractive
Sanofi
gets rated buy today, agreeing with bullish ratings from the Wall Street and SA analysts' consensus. With a diverse ...
GlobalData on MSN
18h
EMA’s CHMP recommends Sanofi’s Sarclisa approval for multiple myeloma
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of ...
The Pharma Letter
14h
Sanofi investing 40 million euros on expanding Lyon Gerland site
French pharma major Sanofi today announced an investment of 40 million euros ($42.4 million) in its Lyon Gerland ...
FierceBiotech
2d
Sanofi, Formation and OpenAI design AI tool to slash clinical trial timelines
There’s a new Muse in town.
Sanofi
, Formation Bio and OpenAI have joined forces to build an AI-powered tool designed to ...
21h
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 ...
4d
on MSN
CEO of pharma giant Sanofi says businesses should stop ‘AI washing’
However, Paul Hudson, CEO of Sanofi, one of the world's leading biopharmaceutical companies, says executives may need to rein ...
GEN
1d
AI Collaboration Between Sanofi and Healx Will Target Novel Rare Diseases Indications
Healx will use its AI-based drug discovery tech to analyze proprietary Sanofi compound data and identify potential rare ...
3d
Sanofi’s Allegra allergy map helps users find cleaner air routes
To combat this, allergy medication Allegra created Allegra Airways, a website designed to help find and map real-time routes ...
3d
Novavax sees weak Covid vaccine sales, convinced Sanofi can do better
Novavax has made a smaller splash in the U.S. Covid-19 vaccine market than it had hoped. But it's betting on licensing deals ...
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Related topics
Regeneron
Sarclisa
Dupixent
Ai
European Medicines Agency
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