2025– date –
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Pharma & Biotech News
[RWD & Genomics Business Special] 23andMe’s Acquisition Highlights the Challenges and Opportunities in Real-World Data
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 ... -
AI Drug Discovery
[AI Drug Discovery: Reality #1] How Far Has AI Drug Discovery Progressed? Sorting Hype from Reality
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 ... -
Science News
[Science News] Nature Highlight: Small Molecules Restore Mutant Mitochondrial DNA Polymerase Activity
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... -
US Research Life & Career
[US Research Experience and Career Pathways Series #1] 3 Things to Know Before Starting Research in the US
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... -
Therapeutics News
[Science News] Nuclear Pore Complex Dysfunction Underlies ALS/FTD via C9orf72 Mutations: Nature Summary (With My Thoughts)
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... -
Drug Discovery
CAR T Cell Success in Solid GI Tumors: Drug Discovery News Spotlight
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 ... -
Drug Discovery
Epigenetic Editing Expands the Reach of Gene Therapy: Drug Discovery News Spotlight
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... -
Rare & Pediatric Disease
Rare & Pediatric Disease News Vol.3 : New Gene Therapy Approach for Rare Childhood Blindness: Drug Discovery News Spotlight
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 ... -
Oncology FDA Approval
Oncology Drug Approval News Flash: Treosulfan (Grafapex) Approved by FDA for Conditioning Prior to allo-HSCT
【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... -
Oncology FDA Approval
Oncology Drug Approval News Flash: pembrolizumab (Keytruda) FDA Approved for Resectable Head and Neck Squamous Cell Carcinoma
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... -
Oncology FDA Approval
Oncology Drug Approval News Flash: Mitomycin (Zusduri) Approved by FDA for Recurrent Low-Grade Intermediate-Risk NMIBC
【FDA Approval Alert】UroGen Pharma's mitomycin (Zusduri) Approved for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (June 12, 2025) On June 12, 2025, the U.S. FDA approved mitomycin (Zusduri) for adult patient... -
Oncology FDA Approval
Oncology Drug Approval News Flash: Taletrectinib (Ibtrozi) Approved by FDA for ROS1-Positive NSCLC
【FDA Approval Alert】Nuvation Bio's taletrectinib (Ibtrozi) Approved for ROS1-Positive Non-Small Cell Lung Cancer (June 11, 2025) On June 11, 2025, the U.S. FDA approved taletrectinib (Ibtrozi) for adult patients with locally advanced o... -
Oncology FDA Approval
Oncology Drug Approval News Flash: Darolutamide (Nubeqa) Approved by FDA for Metastatic Castration-Sensitive Prostate Cancer
【FDA Approval Alert】Bayer's darolutamide (Nubeqa) Approved for Metastatic Castration-Sensitive Prostate Cancer (June 3, 2025) On June 3, 2025, the U.S. FDA approved darolutamide (Nubeqa) for metastatic castration-sensitive prostate can... -
Oncology FDA Approval
Oncology Drug Approval News Flash: Retifanlimab-dlwr (Zynyz) Approved by FDA for Squamous Cell Carcinoma of the Anal Canal
【FDA Approval Alert】Incyte's retifanlimab-dlwr (Zynyz) Approved for Squamous Cell Carcinoma of the Anal Canal (May 15, 2025) On May 15, 2025, the U.S. FDA approved retifanlimab-dlwr (Zynyz) for adults with inoperable locally recurrent ... -
Oncology FDA Approval
Oncology Drug Approval News Flash: Telisotuzumab Vedotin-tllv (Emrelis) Receives Accelerated FDA Approval for High c-Met NSCLC
【FDA Approval Alert】AbbVie's telisotuzumab vedotin-tllv (Emrelis) Accelerated Approval for High c-Met Non-Small Cell Lung Cancer (May 14, 2025) On May 14, 2025, the U.S. FDA granted accelerated approval to telisotuzumab vedotin-tllv (E... -
Oncology FDA Approval
Oncology Drug Approval News Flash: Belzutifan (Welireg) Approved by FDA for Pheochromocytoma and Paraganglioma
【FDA Approval Alert】Merck's belzutifan (Welireg) Approved for Pheochromocytoma and Paraganglioma (May 14, 2025) On May 14, 2025, the U.S. FDA approved belzutifan (Welireg) for patients aged 12 years and older with locally advanced, unr... -
Oncology FDA Approval
Oncology Drug Approval News Flash: Avutometinib + Defactinib (Avmapki Fakzynja Co-pack) Receives Accelerated FDA Approval for KRAS-Mutated LGSOC
【FDA Approval Alert】Verastem's avutometinib + defactinib Approved for KRAS-Mutated Low-Grade Serous Ovarian Cancer (May 8, 2025) On May 8, 2025, the U.S. FDA granted accelerated approval to avutometinib + defactinib (Avmapki Fakzynja C... -
Oncology FDA Approval
Oncology Drug Approval News Flash: Penpulimab-kcqx (Akeso) Approved by FDA for Non-Keratinizing Nasopharyngeal Carcinoma
【FDA Approval Alert】Akeso's penpulimab-kcqx Approved for Non-Keratinizing Nasopharyngeal Carcinoma (April 23, 2025) On April 23, 2025, the U.S. FDA approved penpulimab-kcqx (Akeso) for adult patients with recurrent or metastatic non-ke... -
Oncology FDA Approval
Oncology Drug Approval News Flash: Nivolumab + Ipilimumab (Opdivo + Yervoy) Approved by FDA for Advanced Hepatocellular Carcinoma
【FDA Approval Alert】Bristol Myers Squibb's nivolumab + ipilimumab Approved for Advanced Hepatocellular Carcinoma (April 11, 2025) On April 11, 2025, the U.S. FDA approved nivolumab (Opdivo) plus ipilimumab (Yervoy) as first-line treatm... -
Oncology FDA Approval
Oncology Drug Approval News Flash: Nivolumab + Ipilimumab (Opdivo + Yervoy) Approved by FDA for MSI-H/dMMR Colorectal Cancer
【FDA Approval Alert】Bristol Myers Squibb's nivolumab + ipilimumab Approved for MSI-H/dMMR Colorectal Cancer (April 8, 2025) On April 8, 2025, the U.S. FDA approved nivolumab (Opdivo) plus ipilimumab (Yervoy) for adults and pediatric pa...