Keeping Track: US FDA Approves Spinraza And Rubraca, Delays Ocrevus; Plus Submissions Galore

As the winter holiday season builds to its crescendo, FDA has seen a flurry of activity.

Notably absent, however, was much hope for a significant last-minute burst of new molecular entity and novel biologic approvals. One of the leading candidates, Roche's Ocrevus (ocrelizumab), had its user fee goal extended three months so FDA could review additional information on the commercial manufacturing process. The CD20-targeting antibody for relapsing and primary progressive multiple sclerosis is now in line for action by March 28, 2017