February started emphatically at the US FDA, with novel approvals from both the drugs and biologics centers, including the first biologic with a Regenerative Medicine Advanced Therapy (RMAT) designation to reach approval. (See sidebar for story on approval of Bristol Myers Squibb Company’s CAR-T therapy Breyanzi.)
The Center for Drug Evaluation and Research opened the month with two targeted oncology approvals, TG Therapeutics, Inc.’s Ukoniq...