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Keeping Track: NME Approvals For Evenity And Balversa; Non-NME Approvals For Dovato And Keytruda; But An RTF For Fintepla

 
• By Michael Cipriano and Bridget Silverman

The latest drug development news and highlights from our US FDA Performance Tracker. 

Keeping Track Feature image

With the thumbs up for Amgen Inc.'s Evenity (romosozumab-aqqg) and Janssen Pharmaceutical Cos.'s Balversa (erdafitinib), the US FDA's Center for Drug Evaluation and Research issued its seventh and eighth novel product approvals of 2019.

ViiV Healthcare  made noise on the non-novel drug front with an FDA nod for Dovato (dolutegravir and lamivudine), which became the first two-drug, fixed-dose, complete regimen for newly diagnosed HIV-infected adults. And Merck & Co. Inc

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