The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.

Oral presentation shares head-to-head results for investigational combination pozelimab plus cemdisiran vs. ravulizumab in paroxysmal nocturnal hemoglobinuria Initial results for odronextamab in first ...

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 ...

Dallas salon owner Shelley Luther discusses her comeback after being jailed for keeping her small business open during COVID ...

The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.

Statement/Regulatory AdmissionAflibercept-Biosimilar FYB203 / AHZANTIVE®/ Baiama® receives positive CHMP Opinion from EMA15-Nov-2024 / 18:18 CET/CESTDisclosure of an inside information acc. to Article ...

The FDA has provided a date of April 18, 2025, to review the application for Dupixent to treat patients with chronic ...

Politics will matter greatly for the biotechnology and healthcare sectors. On Thursday, President-elect Trump said that ...

A biotech startup’s journey to unicorn status hinges on its leadership and the culture fostered within the organization. A ...

Looking at options history for Regeneron Pharmaceuticals REGN we detected 8 trades. If we consider the specifics of each ...

Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License ...

Now, it's up to the European Commission to confirm those potential green lights in the coming weeks and months.