FDA– tag –
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Oncology Drug Approval News Flash: Sunvozertinib (Zegfrovy) Approved for EGFR Exon20 Insertion-Positive NSCLC
[FDA Accelerated Approval] New Oral TKI for Advanced NSCLC with EGFR Exon20 Insertions On July 2, 2025, the FDA granted accelerated approval to Sunvozertinib (brand name: Zegfrovy) for the treatment of adult patients with locally advance... -
FDA Treatment News: FDA Eliminates REMS for Autologous CAR-T Cell Therapies
[Regulatory Update] FDA Removes REMS Requirements for Approved CAR-T Therapies In June 2025, the U.S. Food and Drug Administration (FDA) officially eliminated Risk Evaluation and Mitigation Strategies (REMS) requirements for autologous c... -
Rare & Pediatric Disease News Vol.2: How Far Can Japan Catch Up in Pediatric Rare Disease Drug Development?
– Global Comparison and Future Perspectives in the Post-PRV Era – With the expiration of the U.S. FDA’s Rare Pediatric Disease Priority Review Voucher (PRV) program in 2024, a global debate has emerged about how to sustain innovation in ... -
Rare & Pediatric Disease News Vol.1
🧒 Introduction: Why Focus on Pediatric Rare Diseases? Pediatric rare diseases often involve life-threatening conditions with few treatment options. In 2012, the U.S. introduced the Rare Pediatric Disease Priority Review Voucher (PRV) pr...
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