Drug Approval
Pfizer Advances Australian-Discovered KAT6 Inhibitor PF-07248144 into Phase 3 Trial for Advanced Breast Cancer
Australian biotechnology investment and commercialisation incubator, Oncology One Pty Ltd, is pleased to report that PF-07248144, Pfizer Inc's clinica...
September 16, 2025 | News
Akeso Doses First Patient in Global Phase II Registrational Trial of Cadonilimab Plus Lenvatinib for IO-Pretreated Advanced HCC
Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the first patient has been dosed in its global, multicenter, randomized Phase II regi...
September 16, 2025 | News
Biostar Pharma Doses First Patients in Two Global Phase II/III Trials of Oral Utidelone Capsule for Gastric and Ovarian Cancers
Biostar Pharma, Inc., the US subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. ("Biostar", Stock Code: 2563.HK) which is a synthetic biolo...
September 16, 2025 | News
BioAge Advances BGE-102 into Phase 1 Trials Triggering Milestone Payment to HitGen as DEL Technology Accelerates Drug Discovery
BGE-102, an orally available, brain-penetrant NLRP3 inhibitor, was developed from a hit compound identified using HitGen's industry-leading DEL technolog...
September 16, 2025 | News
Alphamab Oncology’s NDA for KN026 Accepted by NMPA for HER2-Positive Gastric Cancer
Alphamab Oncology announced that the New Drug Application (NDA) for anbenitamab injection (KN026), independently developed by the Company and co-developed ...
September 15, 2025 | News
China Grants First Approval for Tzield to Delay Onset of Type 1 Diabetes
Approval based on the TN-10 study, demonstrating Tzield’s ability to delay the onset of stage 3 T1D in adult and pediatric patients aged eight year...
September 11, 2025 | News
Takeda Wins U.S. FDA Approval to Expand VONVENDI Use in Adults and Children with Von Willebrand Disease
Approval Expands Use of VONVENDI to Include Routine Prophylaxis to Reduce the Frequency of Bleeding Episodes in Adults with Type 1 and 2 Von Willebrand D...
September 08, 2025 | Regulatory
Stallergenes Greer and Nuance Pharma Enter Exclusive Partnership to Develop and Commercialise Actair® in China
Stallergenes Greer, a global leader in allergy therapeutics, and Nuance Pharma, an innovation-focused biopharmaceutical company based in China, announced t...
September 05, 2025 | News
China’s Bon Natural Life Unveils Tea-Derived Compounds for Weight Management Through AI-Powered Drug Discovery
Bon Natural Life Limited , a leading bio-ingredient solution provider in the natural, health and personal care industry, announced a groundbreaking identif...
September 03, 2025 | News
Daiichi Sankyo Europe Initiates Development of Oral Triple Combination Tablets to Enhance LDL-C Management
Daiichi Sankyo Europe announced the initiation of the development of new oral triple combination tablets in Europe containing bempedoic acid, ezetimibe, an...
September 02, 2025 | News
FDA Approves Subcutaneous Leqembi Iqlik, Ushering in a New Era of Alzheimer’s Treatment
U.S. Food and Drug Administration (FDA) announced its approval of a subcutaneous formulation of Leqembi (lecanemab), branded as Leqembi Iql...
September 01, 2025 | News
China’s D3 Bio Secures FDA Breakthrough and Orphan Drug Designations for KRAS G12C Inhibitor D3S-001
Breakthrough Therapy Designation was granted for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cel...
August 29, 2025 | News
MS Pharma Inaugurates Middle East’s First SFDA-Approved Biologics Manufacturing Facility In Saudi Arabia
MS Pharma inaugurates Middle East's first biologics manufacturing facility in Saudi Arabia, SFDA-approved and built to meet EMA and F...
August 28, 2025 | News
Abbott Secures Thailand Approval For Denosumab Biosimilar Expanding Access To Osteoporosis Treatment
Abbott denosumab biosimilar has received regulatory approval in Thailand, expanding access to advanced therapies for osteoporosis and cancer-related bone l...
August 27, 2025 | News
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