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Sanofi, Regeneron Dupixent sBLA accepted for USFDA review for chronic spontaneous urticaria

Paris: Sanofi and Regeneron has announced that the US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental biologics license application (sBLA)

GlobalData on MSN · 1d

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.

Benzinga.com · 2d

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.

Business Insider · 1d

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

MarketWatch · 2d

Regeneron, Sanofi Get New FDA Review of Dupixent for CSU

Regeneron Pharmaceuticals and Sanofi said the U.S. Food and Drug Administration has accepted their resubmitted application seeking expanded approval of the blockbuster anti-inflammatory drug Dupixent for the inflammatory skin condition chronic spontaneous urticaria,

Seeking Alpha4d

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 ...

5don 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 ...

FierceBiotech4d

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 ...

GlobalData on MSN2d

EMA’s CHMP recommends Sanofi’s Sarclisa approval for multiple myeloma

Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sanofi’s Sarclisa combined with Velcade ...

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

Further boosting the pipeline, mid-stage drugs like Sanofi/Regeneron’s itepekimab, AstraZeneca’s benralizumab, Amgen Inc ...

Sarclisa recommended for EU approval by CHMP to treat transplant-ineligible newly diagnosed multiple myeloma: Sanofi

Paris: Sanofi has announced that the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) ...

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 ...

2d

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 ...

The Pharma Letter1d

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 ...

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