NCNP-02
- Generic Name
- NCNP-02
Japan Recommends Approval for Brukinsa and Balversa; Grants Sakigake Designation to Brogidirsen and Iclepertin
• Japan's health authorities are set to approve Brukinsa (zanubrutinib) for hematological malignancies and Balversa (erdafitinib) for urothelial carcinoma, expanding treatment options for these cancers.
• Brogidirsen, a gene therapy for Duchenne Muscular Dystrophy (DMD), and Iclepertin are slated to receive Sakigake designation, expediting their development and potential approval.
• The Pharmaceuticals and Medical Devices Agency (PMDA) has established a full-time office in the US, enhancing regulatory collaboration and oversight.
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