Keeping Track: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas

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

Keeping Track Feature image
Krystal Biotech's Vyjuvek is a topical, noninvasive gene therapy.

In a week without US novel approvals, a nearly 10-year-old combination of targeted oncology drugs took the spotlight when Novartis AG's Tafinlar/Mekinist received the Food and Drug Administration’s sixth tumor-agnostic drug approval in five years. 

Novel agents were more plentiful on the submission side. The new new drug applications included two non-hormonal drugs waiting to enter fields with extensive hormonal options, Menarini Group/Radius Health, Inc.'s elacestrant in breast cancer and Astellas Pharma, Inc

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