BioPharma Drug Approval
Lynk Pharmaceuticals Reports Sustained Phase III Efficacy of Zemprocitinib in Rheumatoid Arthritis Through Week 76
Lynk Pharmaceuticals Co., Ltd. ("Lynk Pharmaceuticals"), a clinical-stage innovative drug development company focused on immune and inflammatory diseases, ...
October 29, 2026 | News
EU Approves Daiichi Sankyo and AstraZeneca’s Enhertu for Early HER2-Positive Breast Cancer
Approval based on DESTINY-Breast05 phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s Enhertu reduced the risk of invasive diseas...
October 28, 2026 | News
Orphan Drug Incentives in 9 APAC Markets, Compared
Every January, regulatory affairs teams across Asia-Pacific rebuild the same spreadsheet. Which markets will designate this asset as an orphan? Which will ...
October 27, 2026 | Analysis
Menarini and Georgiamune Strike $1.1 Billion Licensing Deal to Advance Next-Generation Cancer Immunotherapy
GIM-621 is a preclinical-stage, first-in-class oral small molecule immunotherapy with potential application across multiple solid tumors. Georgiamune to...
October 27, 2026 | News
Harbour BioMed Secures China’s NMPA Approval for Batoclimab, Expanding Treatment Options for Myasthenia Gravis
Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics i...
October 26, 2026 | News
Geneos Launches Global Phase 2 Trial of Personalised Cancer Vaccine to Prevent Liver Cancer Recurrence
Geneos Therapeutics, a clinical stage biotherapeutics company focused on the development of neoantigen-based personalized immunotherapy for cancer (PIC), a...
October 23, 2026 | News
Patronus Biotech Secures Australian Approval for First-in-Human Trial of Next-Generation Malaria Vaccines
Bellberry Limited Research Ethics Committee approves first-in-human study in Australia of Patronus Biotech's novel multi-stage virus-like-particle (VLP)-ba...
October 22, 2026 | News
Metabolon Launches AI-Enabled Splash & Ripple to Accelerate Metabolomics-Driven Drug Discovery
New bioinformatics application combines curated metabolite-protein knowledge, advanced network algorithms, interactive exploration, and optional AI interpr...
October 22, 2026 | News
Ascletis Reports Promising Preclinical Data for Once-Weekly Oral Obesity Treatments, Advances US Phase 1 Trial
Ascletis' industry-leading once-weekly oral peptide pipeline covers all four validated targets, with multiple first-in-class fixed-dose combina...
October 21, 2026 | News
PharmaEssentia Accelerates Global Expansion with US and Japan Drug Approvals and US$46 Million Manufacturing Investment
PharmaEssentia Corporation (TWSE: 6446), a Taiwan-based biopharmaceutical company, is expanding its global presence through new drug approvals, clini...
October 21, 2026 | News
Chipscreen Biosciences Secures China IND Approval for First-in-Class Cancer Immunotherapy NW001
Shenzhen Chipscreen Biosciences Co., Ltd. announced that NW001, a first-in-class epigenetic immune-modulating antibody conjugate (EIMAC) co-developed with ...
October 21, 2026 | News
Takeda’s First-in-Class Narcolepsy Drug ORZEYFUL Enters Japan and China Markets Following Regulatory Approvals
ORZEYFUL is now available in Japan and China following approvals within a month of each other by China’s National Medical Products Administration (...
October 16, 2026 | News
Shanghai Ark Biopharmaceutical Secures US FDA IND Clearance for Phase II Trial of Long-Acting Influenza Prevention Drug AK0406
Shanghai Ark Biopharmaceutical announced that the U.S. Food and Drug Administration (FDA) has granted its investigational new drug (IND) application for AK...
October 14, 2026 | News
Asieris Pharmaceuticals and Theramex Sign Over $250 Million Licensing Deal for Cervical Precancer Therapy CEVIRA
Agreement is expected to grant Theramex exclusive rights to CEVIRA® in Europe, Australia, New Zealand and Turkey, while Asieris retains rights for th...
October 13, 2026 | News
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