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.

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.

Around a third of Trevena’s workforce are facing the ax as the biotech throws all its weight behind soon-to-be-filed injectable pain therapy Olinvo.

Elligo Health Research will test a harmonized real-word data model built by the FDA.

The FDA agreed with the efficacy conclusion Aerie reached to support its bid for approval of glaucoma and ocular hypertension hopeful Rhopressa.

Regulatory