FDA to Hold Public Symposium on Multi-Identification Biomarkers

CGT Catapult Invests in Spliceor Trans-Splicing Gene Therapy Platform

The agency has extended the review period for GSK’s biologics license application for belantamab mafodotin-blmf for the treatment of relapsed/refractory multiple myeloma.

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FDA Grants Regenerative Medicine Advanced Therapy Designation to Gene Therapy for Knee OA

The investment is part of CGT Catapult’s Cross-Catapult Investment Pilot and will accelerate the pre-clinical development of Spliceor’s trans-splicing gene therapy platform.

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MIT Researchers Identify Compounds that Fight Viral Infections

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

GSK Seeks Expanded Use Approval from FDA for RSV Vaccine Arexvy

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

Cellular Origins, Cell and Gene Therapy Catapult, and Resolution Therapeutics Form CGT Manufacturing Consortium

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.

FDA Extends Review Period for GSK’s Blenrep

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

Related Content

CGT Catapult Invests in Spliceor Trans-Splicing Gene Therapy Platform

The agency has extended the review period for GSK’s biologics license application for belantamab mafodotin-blmf for the treatment of relapsed/refractory multiple myeloma.

FDA Grants Regenerative Medicine Advanced Therapy Designation to Gene Therapy for Knee OA

The investment is part of CGT Catapult’s Cross-Catapult Investment Pilot and will accelerate the pre-clinical development of Spliceor’s trans-splicing gene therapy platform.

MIT Researchers Identify Compounds that Fight Viral Infections

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

GSK Seeks Expanded Use Approval from FDA for RSV Vaccine Arexvy

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

Cellular Origins, Cell and Gene Therapy Catapult, and Resolution Therapeutics Form CGT Manufacturing Consortium

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.