Bayer’s Kerendia Gets FDA Priority Review for Heart Failure with Preserved Ejection Fraction
German pharmaceutical giant Bayer (ETR: BAYN) announced that a supplementary New Drug Application (sNDA) for...
Drug
Livzon Pharmaceutical Receives Approval for Clinical Trials of Adjuvanted Influenza Vaccine LZSN2401
China-based Livzon Pharmaceutical Group Inc. (HKG: 1513) announced receiving clinical trial approval for its investigational...
Rona Therapeutics Initiates Phase II Study for RN0361 in Severe Hypertriglyceridemia
Shanghai-based Rona Therapeutics Inc. announced receiving approval from the US Food and Drug Administration (FDA)...
Hengrui Pharmaceuticals Receives NMPA Clearance for HRS-6213 in Solid Tumor Diagnosis
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving clearance from the National Medical...
Alphamab Oncology’s JSKN033 Receives Breakthrough Therapy Designation for Platinum Resistant Ovarian Cancer
China-based Alphamab Oncology (HKG: 9966) announced receiving Breakthrough Therapy Designation (BTD) from the National Medical...
Merck & Co.’s Winrevair Approved for Pulmonary Arterial Hypertension in Hainan
US-based giant Merck & Co., Inc. (NYSE: MRK) announced receiving approval from the Hainan Medical...
Visirna Therapeutics Announces Positive Phase III Results for Plozasiran in FCS Treatment
Shanghai-based Visirna Therapeutics announced positive topline results from the Phase III study of plozasiran in...
Basilea Pharmaceutica Marks Milestone as Cresemba Sales Soar in Asia Pacific
Switzerland-based Basilea Pharmaceutica Ltd (SWX: BSLN) announced that its antifungal Cresemba (isavuconazole), commercialized by Pfizer...
BMS’s Breyanzi Approved by EC for Relapsed or Refractory Follicular Lymphoma
US giant Bristol-Myers Squibb (BMS; NYSE: BMY) announced receiving another indication approval from the European...
Life Molecular Imaging Launches Neuraceq in Hong Kong for Alzheimer’s Detection
Life Molecular Imaging Ltd., a subsidiary of South Africa’s Life Healthcare Group focused on PET...
Frontera Therapeutics Receives NMPA Approval for FT-003 in Diabetic Retinopathy Study
Sino-US firm Frontera Therapeutics, Inc. announced receiving approval from China’s National Medical Products Administration (NMPA)...
Jiangsu Hengrui Pharmaceuticals’ Tegileridine Approved for Postoperative Pain Management
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving another indication approval from the...
Doma Biopharmaceutical’s HER3-MUC1 Targeted ADC DM002 Receives NMPA Clinical Approval
China-based Doma Biopharmaceutical (Suzhou) Co., Ltd announced receiving clinical approval from the National Medical Products...
Akeso Biopharma’s Penpulimab Approved for First-Line NPC Treatment
China-based Akeso Biopharma (HKG: 9926) announced receiving another indication approval from the National Medical Products...
Innovent Biologics’ Sycume Approved by China’s NMPA for Thyroid Eye Disease
China-based Innovent Biologics Inc. (HKG: 1801) announced that its New Drug Application (NDA) for Sycume...
Simcere Pharmaceutical’s ADC189 NDA Accepted for Influenza Treatment
Simcere Pharmaceutical Group Limited (HKG: 2096) and AnDiConBio announced that the New Drug Application (NDA)...
Roche’s Itovebi Approved in China for PIK3CA-Mutated Breast Cancer
Itovebi (inavolisib), a best-in-class PI3Kα inhibitor from Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY), has...
CSPC Pharmaceutical Group Receives FDA Approval for SYH2051 Clinical Trial
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced receiving approval from the US Food and...
Bio-Thera Solutions’ BAT2506 Biosimilar Accepted for Review by China’s NMPA
China-based Bio-Thera Solutions Inc. (SHA: 688177) announced that a market filing for its BAT2506, a...
Otsuka and Lundbeck Win EU Approval for Rxulti in Adolescent Schizophrenia
Japan-based Otsuka Pharmaceutical Co., Ltd and its Danish partner Lundbeck A/S (OTCMKTS: HLUBF) jointly announced...