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Keeping Track: Gavreto, Sogroya Bring Annual CDER Novel Approvals To 40; New Analgesic Products Make It Past US FDA

 
• By Bridget Silverman

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

Keeping Track Feature image

The US Food and Drug Administration’s recent approvals include three new molecular entities, bring the Center for Drug Evaluation and Research’s novel approval count for the year to 40.

The new novel products come from different therapy areas: Blueprint Medicines Corporation’s targeted oncologic Gavreto, Novo Nordisk A/S’s growth hormone replacement Sogroya, and RadioMedix, Inc.’s Detectnet, a radioactive diagnostic imaging agent

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