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 ...
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 ...
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 ...