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Keeping Track: Travere’s Filspari, Chiesi’s Lamzede, Apellis’ Syfovre Headline US FDA Approvals; CRLs For Phathom, Biocon

 
• By Bridget Silverman

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

Keeping Track Feature image
Busy week included approval of Apellis’ age-related macular degeneration treatment and an application for the first China-developed biosimilar in the US.

The US Food and Drug Administration closed out last week with the approvals of two novel agents for rare diseases, Travere Therapeutics, Inc.'s Filspari for IgA nephropathy and Chiesi Global Rare Diseases’ Lamzede in alpha-mannosidosis.

Filspari and Lamzede bring the Center for Drug Evaluation and Research’s novel agent count for 2023 to seven approvals.

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