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

US FDA Performance Tracker Approvals

FDA OKs Blueprint/Roche's Gavreto As Rival To Lilly's Retevmo

Regulators in the US have approved Gavreto for metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer, setting the stage for a head-to-head battle for market share with Eli Lilly's Retevmo.

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EMA Says Yes To GSK’s Belantamab But Rejects Tagraxofusp & Emapalumab

GlaxoSmithKline's first-of-its kind treatment for multiple myeloma is among 11 new medicines that have won an EU approval nod from the European Medicines Agency this week.

Europe Approvals

GSK's Belantamab Among Drugs Seeking EU Approval Nod

GlaxoSmithKline's potential multiple myeloma treatment is one of several new products that could get an EU marketing thumbs up from the European Medicines Agency this week.

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