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sBLA, Dupixent and FDA

FDA to review Sanofi and Regeneron’s Dupixent sBLA for bullous pemphigoid

As Sanofi and Regeneron await the FDA decision, a legal dispute between the partners over commercialisation details continues.

Business Insider · 1d

Regeneron, Sanofi announce Dupixent sBLA accepted for priority review by FDA

Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the supplemental biologics license application for

Zacks.com on MSN · 1d

SNY and REGN's Dupixent sBLA for Skin Disease Gets FDA's Priority Tag

Sanofi SNY and partner Regeneron REGN announced that the FDA has accepted their supplemental biologics license application (sBLA) seeking approval for Dupixent for treating bullous pemphigoid (BP), a chronic,

pharmaphorum6y

FDA to review Sanofi's Dupixent in asthma

This makes the new indication for Dupixent very important for Sanofi as it searches for a blockbuster to transform its fortunes. The FDA is set to make a decision on Dupixent’s new indication on ...

Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for the Targeted Treatment of Bullous Pemphigoid (BP)

If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S.; FDA decision expected by June 20, 2025Priority ...

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sBLA, Dupixent and FDA

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