On 13 July 2026, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Allocetra™, an immunotherapy for age-related knee osteoarthritis, which may expedite its development and review. Additionally, recent reports confirm that NICE continues to exclude the injectable hydrogel Arthrosamid from routine NHS use due to insufficient evidence, while a new PDUFA target date of 24 April 2027 has been set for the regenerative treatment ReNu.
- Allocetra FDA RMAT Designation: On 13 July 2026, the FDA granted RMAT designation to Enlivex's Allocetra™ for treating symptomatic knee osteoarthritis in patients aged 64 and older, following successful Phase I/IIa trial results.
- NICE Status for Arthrosamid: As of July 2026, the National Institute for Health and Care Excellence (NICE) maintains that Arthrosamid is not recommended for routine NHS use, despite its availability in private clinics, citing a lack of long-term evidence.
- ReNu FDA Review Timeline: Following the acceptance of its Biologics License Application (BLA) in early July 2026, the FDA has assigned a PDUFA target action date of 24 April 2027 for the regenerative knee treatment ReNu. Calendar file (.ics) ReNu FDA PDUFA Target Date April 24, 2027
- Stanford Cartilage Research News: On 13 July 2026, medical reports highlighted a Stanford University breakthrough involving the 15-PGDH protein, which successfully triggered cartilage growth in human tissue samples, though it remains in the research stage.