Shares in Acorda Therapeutics are sliding following the news that the company’s Parkinson’s drug has been linked to a potentially fatal side effect.

FDA Commissioner Scott Gottlieb has hit back at plans that could see the Pentagon take control over the approval of some experimental drugs and devices for…

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.

The antisense drug triggered a 20-point improvement against a score of neuropathy impairment, laying a marker for the upcoming showdown with Alnylam.

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