The US Food and Drug Administration closed out last week with two novel approvals, both for first-in-class products that hold breakthrough therapy designations: Regeneron Pharmaceuticals, Inc.’s Evkeeza (evinacumab-dgnb) for a rare genetic hypercholesterolemia and G1 Therapeutics Inc.’s Cosela (trilaciclib) for myelopreservation in advanced small cell lung cancer patients receiving chemotherapy.
Regeneron doubled down on approvals with FDA clearance of new uses for Libtayo (cemiplimab-rwlc), its immuno-oncologic partnered with Sanofi.
