Biologics

The latest biologics news — tracking drug development, clinical milestones, regulatory approvals, and deals across the fast-moving world of biologic medicines.

Brought to you by:
FDA
Biotech

Capricor secures reprieve as FDA extends DMD cell therapy review

The FDA deferred its decision to review information the biotech submitted after a negative advisory committee vote.
Nick Paul Taylor Aug 25, 2026 3:26am
Dont cross signal on city street

Regenxbio gene therapy refiling plan derailed by FDA hold

Aug 24, 2026 7:51am
fired layoffs cut executives dismissed

Kolon TissueGene shrinks workforce after pivotal trial miss

Aug 18, 2026 4:00pm
Gene editing CRISPR gene therapy

After 2 undisclosed deaths, can China’s IIT still be trusted?

Aug 17, 2026 7:20am
pivot change turnaround direction walk away

Capricor soars on plan to amend DMD filing after adcomm setback

Aug 14, 2026 10:20am
sold

PTC bets $211M on ‘special opportunity’ to enter Fabry market

Aug 13, 2026 8:15am