The gene silencing pioneer expects to complete the submission by the end of the year, setting it up to win approval in the U.S. in 2018.

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…

We kick off a new long form series assessing the life science industry from its leaders with ex-Teva chief Jeremy Levin.

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…

A tax credit that allows biopharma companies to recoup some of the cost of developing drugs for rare diseases could be abolished if a Republican tax reform…

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.