April 18th 2025
Dupixent is the first new targeted therapy to receive FDA-approval for chronic spontaneous urticaria in adults and adolescents over 12 years of age in over a decade.
FDA Grants Priority Review to Dupixent for Uncontrolled Chronic Obstructive Pulmonary Disease
February 23rd 2024The FDA has assigned a supplemental Biologics License Application submitted by Regeneron and Sanofi for Dupixent in the treatment of COPD with type 2 inflammation with a PDUFA date of June 27, 2024.
FDA Grants Priority Review to Merck’s Keytruda Combo for Endometrial Carcinoma
February 21st 2024Merck seeks approval for Keytruda (pembrolizumab) plus chemotherapy with carboplatin and paclitaxel for patients with primary advanced or recurrent endometrial carcinoma, alongside chemotherapy (carboplatin and paclitaxel).