Astellas Resubmits FDA Application for Vyloy as Treatment for CLDN18.2-Positive Cancer
Astellas Pharma Inc. (TYO: 4503), a Japanese pharmaceutical company, has resubmitted its first-in-class anti-CLDN18.2 biologic...
Market approval filings
CStone Pharmaceuticals’ Sugemalimab Receives Positive CHMP Opinion for NSCLC Treatment in Europe
CStone Pharmaceuticals (HKG: 2616), a biopharmaceutical company based in China, has announced that it has...
Sino Medical Sciences’ Innovative Drug-Coated Stent System Accepted for NMPA Review
Sino Medical Sciences Technology Inc. (SHA: 688108), a China-based medical technology company, has announced that...
Boan Biotech’s Dulaglutide Biosimilar Accepted for Review by China’s CDE
Boan Biotech (HKG: 6955), a biopharmaceutical company based in China, has announced that the Center...
Boan Biotech’s Dulaglutide Biosimilar Accepted for Review by China’s CDE
Boan Biotech (HKG: 6955), a biopharmaceutical company based in China, has announced that the Center...
Henlius Biotech’s Denosumab Biosimilar Secures EMA Review for European Market Entry
Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced that...
Shanghai Fosun Pharma’s FCN-159 File for Dendritic and Histiocytic Tumors Accepted by China’s NMPA
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National...
Innovent Biologics’ IBI311 New Drug Application Accepted for Review by China’s CDE
Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company in China, has announced that the...
NMPA Accepts Jiangsu Yahong Meditech’s Application for Cervical HSIL Treatment Cevira
Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer treatments in...
Huadong Medicine’s EGFR Inhibitor Mefatinib for NSCLC Accepted by NMPA for Review
Huadong Medicine Co., Ltd (SHE: 000963), a leading pharmaceutical company based in China, has announced...
FDA Reviews BMS’ Opdivo Subcutaneous Formulation for Broad Indications
The US Food and Drug Administration (FDA) has agreed to review a submission from Bristol-Myers...
LEO Pharma’s Enstilar Outperforms Daivobet in Phase III Psoriasis Trial in China
Denmark-based dermatology specialist LEO Pharma A/S has announced positive outcomes for its drug candidate Enstilar...
Merus’s Zenocutuzumab Receives Priority Review Status from FDA for Lung and Pancreatic Cancer Indications
Dutch biotechnology company Merus (NASDAQ: MRUS) has announced that the US Food and Drug Administration...
Betta Pharmaceuticals Files for Market Approval of CDK4/6 Inhibitor BPI-16350 in China
Betta Pharmaceuticals Co., Ltd (SHE: 300558), a Chinese pharmaceutical company, has announced that it has...
Jacobio Pharma Applies for Approval of KRAS G12C Inhibitor Gecirasib in China
Jacobio Pharma (HKG: 1167), a China-based biopharmaceutical company, has announced the submission of a New...
Keymed Biosciences’ IL-4Rα Monoclonal Antibody for Allergic Rhinitis Accepted by China NMPA
China-based biopharmaceutical company Keymed Biosciences Inc. (HKG: 2162) has announced that the National Medical Products...
Cutia Therapeutics Submits New Drug Application for Androgenic Alopecia Treatment in Hong Kong
Cutia Therapeutics (HKG: 2487), a dermatology-focused pharmaceutical company, has announced the submission of a New...
Bio-Thera Solutions’ BAT1806 Receives Positive CHMP Recommendation for EU Approval
China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that the Committee for Medicinal Products for...
HutchMed’s Partner Takeda Gets CHMP Nod for Fruquintinib as CRC Treatment in Europe
HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its collaborator Takeda (TYO: 4502,...
MicroPort CardioFlow Medtech’s VitaFlow Liberty Receives CE Mark for European Expansion
China-based MicroPort Scientific Corp (HKG: 0853), a leading medical device company, announced that its spin-off,...