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Keeping Track: US FDA Acts On 5 Novel Drugs: Approval For Fotivda, Pepaxto, Azstarys; CRLs For Defencath and Oral Paclitaxel

 
• By Bridget Silverman

The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker

Keeping Track Feature image

The US Food and Drug Administration doubled the size of the 2021 class of novel cancer therapies with the recent approval of AVEO Pharmaceuticals, Inc.’s Fotivda (tivozanib) and Oncopeptides AB’s Pepaxto (melphalan flufenamide).

The Fotivda approval, for third-line renal cell carcinoma, illustrates the persistent strength of kinase inhibitors in oncology. The first two oncologic new molecular entities cleared in 2021, EMD Serono’s Tepmetko (tepotinib) and TG Therapeutics, Inc

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