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Keeping Track: Targeted Oncologics Tepmetko, Ukoniq Cleared; Posimir Earns Opioid-Sparing Language

 
• By Bridget Silverman

The latest US FDA approval news from the Pink Sheet’s US FDA Performance Tracker

Keeping Track Feature image

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 (umbralisib) and EMD Serono’s Tepmetko (tepotinib). With the 22 January approval of Aurinia Pharmaceuticals Inc

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