BioPharma Drug Approval
Telix Submits European Marketing Application For TLX101 Px To Expand Glioma PET Imaging Access
Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces that it has submitted a marketing authorization application (MAA) in Europe ...
February 19, 2026 | News
Eisai Co Ltd Receives Orphan Drug Designation In Japan For Novel Orexin 2 Receptor Agonist E2086
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has received an orphan drug designation for its in-hou...
February 18, 2026 | News
Jyong Biotech Strengthens Preventive Medicine Position With Positive Phase II Data And Asian Expansion
Comprehensive review of recent milestones highlights statistically significant efficacy in prostate cancer prevention, discovery of novel lipid-modul...
February 16, 2026 | News
Alphamab Oncology Advances JSKN003 Into Phase III Trial For HER2 Positive Advanced Colorectal Cancer
Alphamab Oncology (stock code: 9966.HK) announced that the first patient has been successfully dosed in the Phase III clinical study (Study ID: JSKN003-005...
February 16, 2026 | News
ArkBio Receives FDA IND Clearance For AK3280 Phase Two Trial In Idiopathic Pulmonary Fibrosis
Shanghai Ark Biopharmaceutical Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) applicat...
February 13, 2026 | News
Insilico Medicine And China Medical System Forge Multi Project AI Drug Discovery Alliance
Insilico Medicine ("Insilico", 03696.HK), a clinical-stage biotechnology company driven by generative artificial intelligence (AI), China Medical System Ho...
February 12, 2026 | News
Ascletis Advances ASC36 Oral Amylin Tablet With Strong Preclinical Weight Loss Data
Utilizing Ascletis' Peptide Oral Transport ENhancement Technology (POTENT), ASC36 oral tablets achieved absolute oral bioavailability of 6% to 8% at steady...
February 12, 2026 | News
Eisai And Henlius Sign Exclusive Japan Commercialisation Deal For Anti PD 1 Antibody Serplulimab
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Shanghai Henlius Biotech, Inc. (Headquarters: Shanghai, China, CEO:&nbs...
February 10, 2026 | News
Aucta Pharmaceuticals Launches PYQUVI Oral Suspension For Duchenne Muscular Dystrophy In The US
Aucta Pharmaceuticals is pleased to announce the late January launch of PYQUVI oral suspension 22.75 mg/mL. PYQUVI, a corticosteroid indicated f...
February 10, 2026 | News
Kelun Biotech Wins China Approval For Sacituzumab Tirumotecan In Advanced Breast Cancer
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) announced that a new indication application for its TROP2-dir...
February 09, 2026 | News
Australian World First Paediatric mRNA Brain Cancer Trial Signals Expansion Opportunity For Canada And The United States
Landmark Australian study opens new possibilities for children with aggressive brain tumors and signals opportunity for Canada and USA. -- Providence Ther...
February 06, 2026 | News
Everest Medicines Secures Exclusive Asia Pacific Rights To First In Class Dual Target SHPT Therapy MT1013
Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturi...
February 06, 2026 | News
Biosion Doses First Patient In Phase 1 Trial Of Novel Anti SIRPα Antibody BSI 082
Milestone validates the clinical potential of BSI-082 as a synergistic combination partner for antibody-drug conjugates (ADCs) and reinforces Biosion's "In...
February 05, 2026 | News
Insilico Medicine Receives $5 Million Milestone From Menarini Group After First Patient Dosed In Phase 1 Trial Of AI Designed Cancer Therapy
Followed by the development and regulatory milestone payment of USD 3 million in July 2025, Insilico received an additional milestone paymen...
February 05, 2026 | News
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