EMA Seeks Public Consult on Bioequivalence Concept Paper

Genascence’s first-in-class gene therapy blocking interleukin 1, GNSC-001, will enter a Phase IIb/III study in 2026.

The company’s gene therapy, AAVB-039, for the treatment of Stargardt disease progresses to a Phase I/II clinical trial.

Scientists at MIT and other institutions have discovered compounds that activate a defense pathway inside host cells that could be used as antiviral drugs.

FDA will review GSK’s application to expand the use of its respiratory syncytial virus vaccine, Arexvy, to adults aged 18–49 who are at increased risk.

The consortium will focus on the delivery of a fully automated robotics cell and gene therapy manufacturing platform.

Advanced modeling provides greater understanding for more-informed decision making across all phases of drug development.