Donislecel, branded as Lantidra, was approved by the FDA on June 28, 2023. It represents a significant development in the treatment of type 1 diabetes.
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.
Delandistrogene moxeparvovec, known by the brand name Elevidys, received FDA approval for the treatment of Duchenne muscular dystrophy in children on June 22, 2023.
Vyvgart Hytrulo received FDA approval on June 20, 2023. It is approved for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.