The US FDA extends approval for Jemperli (dostarlimab-gxly) combined with chemotherapy to all adults with advanced or recurrent endometrial cancer. It is the first immunotherapy showing overall survival benefits.
REGENXBIO Inc. announced fresh, encouraging interim results on safety and efficacy from the Phase I/II AFFINITY DUCHENNE trial of RGX-202 in Duchenne muscular dystrophy patients aged 1 to 11 years.
Health Canada has authorized the use of Celltrion's Steqeyma®, a biosimilar of Stelara® (ustekinumab), for managing various persistent inflammatory diseases.
SanBio Gains Approval for "AKUUGO® Suspension for Intracranial Use" (INN: Vandefitemcel) to Treat Persistent Motor Paralysis from Traumatic Brain Injuries.
The combination therapy was well tolerated, and the safety profile of BNT111 with cemiplimab was consistent with previous trials of BNT111 with anti-PD-(L)1-based treatments.