Wei Cai (ESALY.US) submitted a rolling supplemental biologics license application to the FDA for the subcutaneous injection formulation of Luncanaidong monoclonal antibody.

Wisdom Finance app learned that on September 4th, Eisai and Biogen announced that Eisai (ESALY.US) has initiated the rolling submission of a supplemental biologics license application (sBLA) for IQLIK, a subcutaneous autoinjector of lenzilumab monoclonal antibody, as a weekly starting dose to the US FDA. The FDA had previously granted fast track designation. Lenzilumab monoclonal antibody is used to treat early-stage Alzheimer's disease patients with mild cognitive impairment and mild dementia.