June 12th 2025
The warning letters deal with a range of violations involving items from personal hygienic products to mismarketed analgesics.
Severe Eosinophilic Asthma Maintenance Treatment Approved in China for Ages 12 and Up
August 20th 2024Fasenra, which has been approved since 2019 in the United States in a pre-filled, single-use auto-injector form that can be administered either in a doctor’s office or at home, is now approved in China for age 12 and up.
GSK’s Application Seeking Blenrep Combinations for Treating Multiple Myeloma Accepted by EMA
July 25th 2024GSK's MAA is supported by an interim analyis of Phase III trials, which demonstrated significant progression-free survival benefit and positive overall survival trends from Blenrep combination therapies.
FDA Draft Guidance Seeks to Support Drug Developers for Pediatric Inflammatory Bowel Disease
July 23rd 2024While the document does not address treatment or prevention of the long-term complications of ulcerative colitis or Crohn’s disease in children, it aims to help sponsors developing drugs for pediatric patients currently affected.