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Keeping Track: J&J’s Targeted Oncologic Rybrevant, Apellis’ C3 Inhibitor Empaveli Approved; New Filings From Takeda, Lilly

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

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J&J’s Rybrevant May Find Limited Uptake Outside Academic Centers

The lung cancer drug’s side effects may deter some community oncologists, while a potentially safer drug earlier in development could prove more attractive.

Apellis' Empaveli Poised To Give Soliris A Run In PNH

The first targeted C3 therapy was approved by the US FDA for treatment-naïve patients as well as those switching from Alexion's Soliris or Ultomiris.

PD-1 Inhibitor Market Poised For A New Round Of Expansion: After GSK’s Jemperli Approval, US FDA Still Has Three Novel Candidates Under Review

Agenus’ recent submission of balstilimab joins novel checkpoint inhibitors from Incyte expecting FDA action this year; Junshi and Coherus’ ongoing rolling BLA for toripalimab is the first from the multiple PD-1/L1 inhibitor candidates developed in China that are vying to enter the US market.

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