Pharmaceutical Companies– tag –
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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) pro... -
[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: 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 ... -
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... -
Cancer Drug 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 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 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 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 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 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...
