Category Regulatory

U.S. Food and Drug Administration Issues Complete Response Letter for Mirikizumab  Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the mirikizumab biologic license application (BLA) for the treatment of ulcerative…

Update on IMBRUVICA® (ibrutinib) U.S. Accelerated Approvals for Mantle Cell Lymphoma and Marginal Zone Lymphoma Indications AbbVie (NYSE: ABBV) announced today the intent to voluntarily withdraw, in the U.S., accelerated IMBRUVICA® (ibrutinib) approvals for patients with the blood cancers mantle cell…