Tags : Zeposia

Insights+: The US FDA New Drug Approvals in March and

The US FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 48 new products so far in 2019. In 2018, the FDA approved 59 novel products including 42 New Chemical Entity and 17 Biologics while breaking its past year’s records of approval. However, there is a […]Read More

BMS’ Zeposia (ozanimod) Receives the US FDA’s Approval as New

Shots: The approval is based on P-III SUNBEAM & RADIANCE Part B studies assessing Zeposia (0.92 mg, equivalent to 1mg) vs Avonex (interferon beta-1a, qw, IM) in 1,346 & 1,320 patients with RMS for at least 12 & 24mos. treatment period respectively Collective results: @1yr. & @2yrs.; reduction in ARR of 48% & 38% (0.18 […]Read More