Keeping Track: US FDA Has Clinical Questions For Tricida, Gilead And BioMarin; Enspryng And Winlevi Approved
Executive Summary
The latest drug approval and decision news from the Pink Sheet’s US FDA Performance Tracker.
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Asia Deal Watch: GC Pharma Looks To Build On Enzyme Replacement Therapy Success
South Korean firm teams with Speragen to develop enzyme-replacement therapy for the genetic disorder and with Mirum for maralixibat. Plus deals involving Takeda/PeptiDream, Hanmi/LegoChem, Sun/Cassiopea, LegoChem/Cellectar, ChubLab/CJ CheilJedang Corp., Alebund/Chugai, Kintor/Fosun, Astellas/ExCellThera and I-Mab/neoX/Immorna.
Keeping Track: Submissions Galore Start The New Year; US FDA Clears New Indications For Enhertu, Xalkori
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker
Roctavian’s Durability: For The Price, Payers Wanted Longer-Term Proof Anyway
FDA’s decision to seek two more years of data for BioMarin’s gene therapy for hemophilia A ‘makes perfect sense,’ Harvard Pilgrim Health Care’s Michael Sherman says.