Keeping Track: US FDA Has Clinical Questions For Tricida, Gilead And BioMarin; Enspryng And Winlevi Approved
The latest drug approval and decision news from the Pink Sheet’s US FDA Performance Tracker.
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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
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.