ipharmacenter Consulting services

Johnson & Johnson achieved a milestone on October 7, 2025, as the U.S. FDA approved Simponi (golimumab) for pediatric patients aged at least 2 years and weighing at least 15 kg, living with moderately to severely active ulcerative colitis (UC). This regulatory win makes Simponi the first biologic approved for children in this patient group that can be administered on a once-monthly schedule-helping young patients manage a complex disease with far fewer treatment disruptions.

Daiichi Sankyo has made significant strides in oncology research and care, announcing several developments in the first week of October.   The company filed for regulatory approval of Enhertu as a first-line therapy for HER2-positive metastatic breast cancer, combining it with pertuzumab to target aggressive, treatment-resistant tumors.   In the U.S., the FDA accepted a supplemental application for a unique regimen offering Enhertu followed by THP before surgery, aiming to im