The FDA last year turned away the companies' application and asked for additional efficacy data. Regeneron and Sanofi said the resubmission adds results from an additional Phase 3 study of Dupixent in ...

The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults and pediatric ...

French drug major Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the U.S. Food and Drug Administration ...

Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore than 300,000 people in the U.S.

Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore ...

HAMPTON, N.J., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the third quarter ended September 30, 2024 and provided a corporate ...

Histamine plays an important role in healthy immune functioning and neurotransmitter signaling. However, when these naturally ...

Explore the potential of Celldex's Barzolvolimab in Phase 3 for CSU, with strong efficacy but safety concerns, promising ...

In November 2021, however, she came up against a case nearly impossible to solve. It all started when Elisha woke up with an ...

Earlier this month, Vice President and presidential nominee Kamala Harris released a report with details about her health and ...

In the half year to 30 September, revenue fell 9.7% $2.37bn, hit in particular by "significant" currency devaluations in Nigeria, Malawi, Zambia and Tanzania. Meanwhile, operating profit was down ...

It can also affect sleep, productivity, and quality of life. Antihistamines may help prevent allergy symptoms. But sometimes you may need to take additional medications. This is especially the ...