Cellectis is now a step closer to restarting enrollment in the studies yet faces new restrictions that will cap how quickly it gets back up to speed.

Just a few months after telling TherapeuticsMD that its treatment for vaginal pain during sexual intercourse lacked data on safety, the FDA has changed its…

Tocagen is moving straight into a phase 3 trial of its gene therapy in cancer and thus needs more patients, but it has also been given a $2 million orphan drug…

The regulatory status sets the prodrug of tramiprosate up to speed through the FDA review process if it bucks the trend and hits the mark in phase 3.

After decades of research, a gene therapy to correct a specific genetic mutation is on the brink of being approved by the FDA.

The National Institutes of Health (NIH) has enlisted the help of 11 top biopharma companies to bring new cancer immunotherapies to patients faster.

The Big Pharma reached the decision after going over a mixed set of data from its big bet on a phase 3 program.

The latest, 60% hit to AcelRx’s stock price followed another run-in with the FDA, which knocked back a filing for approval of pain drug Dsuvia.

Regulatory