Clinical and commercial quality controls are eased as the FDA looks to expedite therapy approvals in areas of unmet need.

A patient death in a CRISPR trial halts gene editing studies, raising critical safety questions. What this means for the ...

"Regulatory flexibility must be tailored for cell and gene therapies," commented FDA Commissioner Marty Makary. "These are ...

It was the priciest biotech startup sale in North Carolina history. Now five years under Bayer, AskBio advances more AAV gene ...

A recent publication in Nature Medicine describes a novel immunotherapy targeting pancreatic cancer that has shown promising ...

Shares of Lexeo Therapeutics (NASDAQ:LXEO) dropped about 17% on Monday after the company published interim Phase I/II results ...

An HIV-derived nucleoside therapy now treats rare genetic diseases by restoring mitochondrial DNA and improving muscle ...

Solid Biosciences Inc. (Nasdaq: SLDB) (the "Company” or "Solid”), a life sciences company developing precision genetic ...

FALCON is a first-in-human, open-label, multi-center Phase 1b clinical trial designed to evaluate the safety and tolerability ...

The Cambridge-based company said the Elevidys results were impacted by a bad flu season at the end of 2025, forcing it to ...

U.K. biotech Ikarovec has teamed up with VectorBuilder to work on an eye disease gene therapy that could be administered in a ...

A preclinical study uncovered a new gene therapy that targets pain centers in the brain while eliminating the risk of ...