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FDA continues to build regenerative medicine pathway

Sep. 26, 2025

The U.S. FDA released a trio of draft guidances to help sponsors in developing and monitoring cell and gene therapies, as well as other regenerative medicine therapies.

BioWorld Regulatory Cell therapy Gene therapy U.S. FDA Orphan drug

Today's news in brief

BioWorld

BioWorld briefs for Dec. 10, 2025.

Today's news in brief

BioWorld MedTech

BioWorld MedTech briefs for Dec. 10, 2025.

Epigenetic technology could eliminate misfolded prion proteins

BioWorld Science

The number of deaths caused by prion diseases reaches about 30,000 annually. Only 5 months pass from the diagnosis of seemingly healthy patients to the fatal...

CTAD 2025: Diagnosing semaglutide’s failure in Alzheimer’s trials

BioWorld

A little over a week after announcing that the Evoke and Evoke+ studies failed to show that oral semaglutide could slow cognition decline in patients with...

Brenig Therapeutics discovers new LRRK2 inhibitors

BioWorld Science

Brenig Therapeutics Inc. has described leucine-rich repeat kinase 2 (LRRK2; dardarin) and (LRRK2; dardarin) (G2019S mutant) inhibitors reported to be useful for...