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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.

Business Insider · 1d

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

Benzinga.com · 1d

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.

MarketWatch · 1d

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,

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

Seeking Alpha3d

Sanofi: Diverse Drug Portfolio And Future Pipeline, 4% Dividend Yield Looks Attractive

Sanofi gets rated buy today, agreeing with bullish ratings from ... therefore I picked 4 big pharma names with a global ...

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 ...

Business Insider4d

Sanofi treatment of acute myeloid leukemia granted orphan status

A treatment of acute myeloid leukemia being developed by Sanofi (SNY) US Services was granted FDA orphan designation, according to a post to the agency’s website. Published first on TheFly – the ...

FierceBiotech3d

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 ...

Yahoo Finance27d

Sanofi’s $17bn sale of Opella to US investors advances following government deal

Sanofi has entered exclusive talks with US private equity company Clayton Dubilier & Rice (CD&R) over the sale of the former’s consumer health business Opella, with a deal also reached with the ...

Reuters26d

Sanofi in exclusive talks with CD&R over sale of $17 billion Opella

"We chose the group with the best capabilities and people that would help us enable the long term success of the business." He added that while there was no timeline for how long Sanofi would be ...

Pharmabiz1d

EMA human medicine committee recommends approval of Sanofi’s Sarclisa to treat transplant-ineligible newly diagnosed multiple myeloma

EMA human medicine committee recommends approval of Sanofi’s Sarclisa to treat transplant-ineligible newly diagnosed multiple myeloma: Paris Saturday, November 16, 2024, 09:00 H ...

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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