The Hill

FDA proposes new treatment approval pathway for ultrarare diseases

The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments addressing ultrarare diseases. The FDA unveiled draft guidance on a proposed ...
STAT

FDA unveils rules for bespoke gene therapies, predicting flood of rare disease applications

Jason Mast is a general assignment reporter at STAT focused on the science behind new medicines and the systems and people that decide whether that science ever reaches patients. You can reach Jason ...
FierceBiotech

UPDATED: FDA illuminates new approval pathway for bespoke gene editing therapies

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...
Forbes

Compass Pathways Phase 3 Results Raise Hopes For FDA Approval Of Psilocybin

Compass Pathways has announced that its investigational psilocybin treatment has successfully met its primary endpoint in a second Phase 3 clinical trial moving it one step closer to FDA submission.