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...
Drug
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...
Viatris Launches Ryzumvi in the US for Rapid Reversal of Pharmacologically-Induced Pupil Dilation
Viatris Inc. (NASDAQ: VTRS) has launched its alpha-adrenergic blocker Ryzumvi (phentolamine) in the US market,...
J&J’s Nipocalimab Fast-Tracked by FDA for Reducing FNAIT Risk in Pregnant Adults
The US Food and Drug Administration (FDA) has accepted Johnson & Johnson’s (J&J; NYSE: JNJ)...
Shanghai Fosun Pharma and Meiji Seika Pharma Launch Phase III Studies for Anti-Infective Nacubactam
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based...
Junshi Biosciences Gets Green Light for Global Phase III Study of Tifcemalimab Combination Therapy in LS-SCLC
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877), a leading biotech company based in China, has...
FDA Reviews Eisai’s Monthly Maintenance Therapy for Early Alzheimer’s with Leqembi
Last week, the US Food and Drug Administration (FDA) announced the acceptance of an indication...