Lilly and Roche expressed their criticism of the draft guidance from the U.S. Centers for Medicare & Medicaid Services (CMS) for Biogen’s Alzheimer’s drug Aduhelm (aducanumab).

Less than one week after posting a positive first-look at Phase III vaccine data, Maryland-based Novavax began the rolling review process for authorization of NVX-CoV2373 in the United Kingdom, Canada and the United States.

Eton Pharmaceuticals Inc. submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for the injectable hospital-use product candidate DS-200 via the Rolling Review process.