Huadong Medicine Gets NMPA Approval for Clinical Trial of FRα-Targeting ADC Elahere
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from...
Drug
Hinova Pharmaceuticals Receives NMPA Greenlight for HP501 Clinical Trial in Gout Patients
Shanghai-based Hinova Pharmaceuticals Inc. (SHA: 688302) has announced that it has received approval from the...
Junshi Biosciences’ Toripalimab Approved for First-Line RCC Treatment in China
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has received a new indication approval...
Ascletis Pharma Halts ASC42 Phase II Study in Primary Biliary Cholangitis
China-based Ascletis Pharma Inc. (HKG: 1672) has announced its decision to terminate the Phase II...
IASO Biotherapeutics Gains FDA Nod for Fucaso CAR-T Study in Myasthenia Gravis
China-based IASO Biotherapeutics has received approval from the U.S. Food and Drug Administration (FDA) to...
Ipsen Secures NMPA Approval for Somatuline in Advanced Neuroendocrine Tumors
Ipsen (EPA: IPN; OTCMKTS: IPSEY), a France-based biopharmaceutical company, has received new indication approval from...
Shanghai Henlius Reports Phase III Success for HLX14 in Osteoporosis Treatment
Shanghai Henlius Biotech Inc. (HKG: 2696), based in China, has announced that its global, multi-center...
Mabwell Bioscience Receives NMPA Approval for Biosimilar Version of Amgen’s Xgeva
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received market approval...
Walvax Biotechnology’s COVID-19 Variant Vaccine RQ3033 Shows Positive Phase III Results
China-based Walvax Biotechnology Co., Ltd (SHE: 300142) has announced positive results from a Phase III...
Legend Biotech’s Carvykti Secures FDA Approval for Expanded Use in Multiple Myeloma
China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced that the US Food and Drug Administration...
European Commission Approves Reblozyl for First-Line Treatment of MDS-Related Anemia
The European Commission (EC) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension...
AstraZeneca and Daiichi Sankyo File for FDA Approval of Datopotamab Deruxtecan in Breast Cancer
AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, and its Japanese partner Daiichi Sankyo (TYO:...
Sichuan Biokin Secures NMPA Approval for Phase II Study of BL-M07D1 in Advanced Solid Tumors
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506), based in China, has announced that it has...
Jiangsu Hengrui’s Fluzoparib Receives Breakthrough Therapy Designation for HER2-Negative Breast Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a China-based pharmaceutical company, has announced that its...
Jiuyuan Gene’s Semaglutide Biosimilar Market Filing Accepted for Review in China
Hangzhou Jiuyuan Gene Engineering Co., Ltd., based in China, has announced that its market approval...
RemeGen Secures Fast-Track FDA Designation for Telitacicept in Sjögren’s Syndrome Treatment
China-based pharmaceutical company RemeGen (HKG: 9995) has announced that it has received fast-track designation (FTD)...
Hepalink Secures TFDA Approval for Enoxaparin Sodium Injection, Expanding Thrombosis Treatment Options in Thailand
Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399), based in China, has announced that it...
Junshi Biosciences Files for Approval of Ongericimab, Targeting Key Cholesterol Disorders
China’s Junshi Biosciences (HKG: 1877; SHA: 688180) has announced the submission of two market approval...
Zai Lab Announces Positive Phase III Data for Krazati in KRASG12C-mutated NSCLC, Plans NDA Filing in China
Zai Lab (NASDAQ: ZLAB; HKG: 9688), a China-based biotech company, has announced positive Phase III...
Alexion’s Voydeya Earns FDA Nod as Add-on Therapy for PNH-Associated Extravascular Hemolysis
Alexion, the rare disease unit of AstraZeneca (AZ; NASDAQ: AZN) based in the UK, has...