FDA To Revisit Regeneron/Sanofi's Dupixent For Rare Skin Disease
Regeneron and Sanofi's Dupixent sBLA for treating chronic spontaneous urticaria in patients 12+ gets FDA review, with a ...
Press Release: Dupixent sBLA accepted for FDA review for the treatment of chronic ...
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 ...
Regeneron, Sanofi announce FDA accepts Dupixent sBLA for review
Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License ...
Regeneron, Sanofi Get New FDA Review of Dupixent for CSU
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 ...
Sanofi, Regeneron's Dupixent SBLA Accepted For FDA Review To Treat Chronic Spontaneous ...
French drug major Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the U.S. Food and Drug Administration ...
PharmiWeb5 小时
Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria
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 ...
Medscape9 天
Predicting and Establishing the Clinical Efficacy of a Histamine H1-Receptor Antagonist
The drug development process is essential to provide an indication of the pharmacotherapeutic potential of an antihistamine and to establish its clinical efficacy. In vitro tests have demonstrated ...
来自MSN6 个月
For Your Patients: What's the Best Treatment for Hives?
For mild hives, your doctor may recommend an over-the-counter, second-generation H1 antihistamine such as fexofenadine (Allegra), loratadine (Claritin), cetirizine (Zyrtec), or desloratadine ...