Last mentioned: Feb 23, 2026
Quicker Path Formalized
Official rollout of the streamlined regulatory framework for gene therapy approvals.
CBER Staffing Surge
FDA completes hiring of 100+ new reviewers dedicated to biologics and gene therapy.
START Pilot Program
FDA launches the Support for clinical Trials Advancing Rare disease Therapeutics pilot.
First Gene Therapy Approved
FDA approves Luxturna for a rare form of inherited vision loss.
The FDA has launched a streamlined regulatory pathway designed to expedite the development and review of gene therapies, particularly for rare diseases. This initiative marks a significant shift toward using surrogate endpoints and flexible trial designs to bring life-saving treatments to market faster.
NG Biotech and Hardy Diagnostics have received FDA Breakthrough Device Designation for two rapid diagnostic assays targeting multidrug-resistant pathogens. The NG-TEST Candida auris and NG-TEST Aci assays provide rapid, point-of-care identification of high-priority healthcare-associated infections.