Keeping Track: J&J’s Targeted Oncologic Rybrevant, Apellis’ C3 Inhibitor Empaveli Approved; New Filings From Takeda, Lilly
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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First-in-class CMV treatment showed better efficacy in refractory patients with genetic resistance than those without; US FDA advisory committee will separately consider benefit-risk in each type of patient. On the safety side, taste disturbance is the only adverse event that stands out.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Apellis plans to file pegcetacoplan for approval as the first drug to treat the advanced AMD condition geographic atrophy, despite the C3 inhibitor hitting its endpoint in only one of two pivotal trials.