The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.
Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by ...
The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.
The FDA has provided a date of April 18, 2025, to review the application for Dupixent to treat patients with chronic ...
Regeneron and Sanofi's Dupixent sBLA for treating chronic spontaneous urticaria in patients 12+ gets FDA review, with a ...
French drug major Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the U.S. Food and Drug Administration ...
A major news story from Sanofi this month is that "The European Medicines Agency has approved Dupixent (dupilumab) to treat ...
Among these, Bristol Myers Squibb, Gilead Sciences and Sanofi stood out with robust growth, while the two leading companies, ...
The companies did not provide detailed data for Tezspire, however, and William Blair’s Matt Phipps said in a note he does not ...
Detailed price information for Kymera Therapeutics Inc (KYMR-Q) from The Globe and Mail including charting and trades.