The US Food and Drug Administration (FDA) has granted fast-track designation to Opexa Therapeutics’ Tovaxin drug candidate, used to treat secondary progressive multiple sclerosis.

The fast-track status will facilitate to develop and expedite the review of drugs intended to treat serious or life-threatening conditions.

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

Fast-track priority review products are expected to be approved during the first review cycle, resulting in a halved review period compared to those without the designation.

Opexa president and CEO Neil Warma said the receipt of fast-track designation will advance Tovaxin through the clinical and regulatory process.

Clinical Trials Arena Excellence Awards - Nominations Closed

Nominations are now closed for the Clinical Trials Arena Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact

Excellence in Action
Science 37 has won the Research and Development Award in the Site Innovation category for its FDA inspected Direct-to-Patient Site model, delivering nationwide access, faster enrollment and higher retention. Explore how its virtual-first, in home approach is reshaping trial operations and accelerating time to data-driven decisions..

Discover the Impact