June 2025– date –

A study published in the June 2025 issue of Cancer Discovery reveals that highly mutated cell clones carrying multiple driver mutations can persist for many years in esophageal squamous epithelium before progressing to esophageal squamou...

– 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 ...

[FDA Accelerated Approval] Datroway by Daiichi Sankyo approved for EGFR-mutated non-small cell lung cancer (June 23, 2025) On June 23, 2025, the U.S. FDA granted accelerated approval to Datopotamab deruxtecan-dlnk (Datroway) for adults w...

CAR T-cell therapy has revolutionized blood cancer treatment but traditionally relies on an ex vivo process—extracting T cells from patients, genetically modifying them outside the body, expanding them, and reinfusing them. This manufact...

Can human cells divide forever? In 1961, Leonard Hayflick and Paul Moorhead provided a clear answer to this question. Their seminal paper demonstrated that normal human diploid cells have a limited number of divisions, introducing the co...

[FDA Approval Alert] Tisotumab vedotin-tftv by Seagen and Genmab approved for recurrent/metastatic cervical cancer (June 21, 2025) On June 21, 2025, the U.S. FDA approved Tisotumab vedotin-tftv (Tivdak) for the treatment of recurrent or ...

A U.S. research team is developing a novel combination therapy of antibody drugs that directly targets the underlying causes of allergic diseases. The strategy simultaneously blocks immunoglobulin E (IgE), a key driver of allergic reacti...

A comprehensive review published in the June 2025 issue of Nature Biotechnology summarizes the current status of personalized mRNA cancer vaccine development. Neoantigen-based mRNA vaccines, tailored to individual patients' tumor mutatio...

A study published in the June 2025 issue of Cell reveals how dynamic transcriptome remodeling orchestrates both entry into and exit from cellular quiescence. This article was selected for the journal's prominent Leading Edge feature, hig...

🧒 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) pro...

23andMe, once one of the largest direct-to-consumer (DTC) genomics companies with a vast database of genetic, familial, and self-reported health data, has entered bankruptcy proceedings. While Regeneron was initially seen as a potential ...

With the rapid evolution of artificial intelligence (AI), the concept of AI Drug Discovery has gained significant attention. Headlines often suggest that AI can now "create new drugs" or "automate drug development," raising expectations ...

A new study published in the June 12, 2025 issue of Nature reports that the small molecule PZL-A can directly restore the function of DNA polymerase gamma (POLγ), impaired by POLG mutations causing severe mitochondrial disorders. This wo...

Starting research in a US laboratory marks an exciting new chapter of growth and challenge for many young researchers. However, the culture, values, and daily research practices in the US can differ considerably from what students may be...

A U.S. research team has revealed that repeat expansions in the C9orf72 gene — a major cause of amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD) — induce dysfunction of the nuclear pore complex (NPC) in neurons. In C...

While CAR T cell therapies have shown success primarily in hematologic malignancies, new advances are emerging for gastrointestinal (GI) solid tumors such as colorectal, gastric, and esophageal cancers. U.S. research teams have reported ...

A U.S. research team has demonstrated the therapeutic potential of epigenetic editing — a strategy that regulates gene expression without altering the DNA or RNA sequence itself. Unlike conventional gene editing, this approach employs pr...

A U.S. research team has developed a novel gene therapy for Leber Congenital Amaurosis (LCA), a rare form of childhood blindness. Unlike conventional AAV-based gene augmentation, this approach utilizes RNA editing technology to directly ...

【FDA Approval Alert】medac's treosulfan (Grafapex) Approved for Conditioning in AML/MDS allo-HSCT (January 21, 2025) On January 21, 2025, the U.S. FDA approved treosulfan (Grafapex) in combination with fludarabine as part of a condition...

FDA Approval Alert: Merck's pembrolizumab (Keytruda) Approved for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (June 12, 2025) On June 12, 2025, the FDA approved pembrolizumab (Keytruda) for the treatment of resectab...