FDA’s new and supplemental approvals in December

FDA ended the year with approval of at least nine new therapies in December, including a subcutaneous formulation of Opdivo that could extend the lifecycle of the product, as patent cliffs loom for the IV versions of the major PD-1 inhibitors.

Bristol Myers Squibb Co. (NYSE:BMY) received approval of subcutaneous Opdivo nivolumab for all the solid tumor indications of intravenous Opdivo. Merck & Co. Inc. (NYSE:MRK) has a subcutaneous version of Keytruda pembrolizumab in Phase III development...