BMS’s Yervoy-Opdivo Combo on Track for Breakthrough Therapy Designation in China for CRC
The China Center for Drug Evaluation (CDE) website has indicated that the market approval filing...
Drug
Pfizer’s RSV Vaccine Demonstrates Durable Efficacy with Abrysvo Phase III Results
Pfizer Inc. (NYSE: PFE) last week reported the outcomes of a Phase III trial for...
Shanghai Fosun Pharma’s GCK-01 CAR-NK Cell Therapy Gets Tacit Clinical Approval from China’s CDE
The China Center for Drug Evaluation (CDE) website has indicated that Shanghai Fosun Pharmaceutical (Group)...
J&J’s Rybrevant Secures Full FDA Approval for NSCLC with EGFR Exon 20 Insertions
The US Food and Drug Administration (FDA) has granted Johnson & Johnson (J&J; NYSE: JNJ)...
Astellas Launches Late-Stage Trial in Japan for Nonhormonal Menopause Treatment
Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, last week initiated a late-stage...
Sino-US Laekna’s LAE102 Clinical Trial Filing Accepted for Review in Obesity and Metabolic Disorders
Sino-US Laekna (HKG: 2105) has announced that its clinical trial application for LAE102, an antibody...
Fosun Pharmaceutical Secures NMPA Approval for Phase II Study of FCN-338 and FCN-647 in Chronic Lymphocytic Leukemia
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that it has...
Shanghai Pharmaceuticals’ MediTrust Health Teams Up with Eisai to Enhance Alzheimer’s Prevention and Treatment
Shanghai Pharmaceuticals Holding Co., Ltd (SHA: 601607, HKG: 2607)’s subsidiary MediTrust Health, which specializes in...
Fosun Pharmaceutical’s HanDaYuan Seeks NMPA Approval for Expanded Indications in Autoimmune Treatments
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National...
Jiangsu Hengrui Receives NMPA Approval for HRS-1167 Clinical Trials in Advanced Solid Tumors
Jiangsu Hengrui Pharmaceutical Co., Ltd (SHA: 600276) has secured clinical trial approval from the National...
Innovent Biologics Launches Phase I Study for IBI3002, a Bispecific Antibody Targeting Asthma
Innovent Biologics, Inc. (HKG: 1801), based in China, has announced the initiation of its Phase...
CDE Grants Priority Review to Jiu An’s Adrenaline and AnHeart’s Taletrectinib; Two Others Earn Breakthrough Therapy Designation
The Center for Drug Evaluation (CDE) has announced that Jiu An Pharmaceutical’s adrenaline and AnHeart...
Huadong Medicine’s MaiLi Extreme Achieves Clinical Study Milestone for Chin Retraction Treatment
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that a Chinese clinical study for...
CARsgen Therapeutics’ BCMA-targeted CAR-T Cell Therapy Approved by China’s NMPA
CARsgen Therapeutics Holdings Ltd (HKG: 2171), a specialist in chimeric antigen receptor (CAR)-T cell therapies...
FDA Withdraws Approval for Multiple Myeloma Drug Pepaxto Over Safety and Efficacy Concerns
The US Food and Drug Administration (FDA) has announced its final decision to withdraw approval...
Chia Tai Tianqing’s Anlotinib-Benmelstobart Combo Therapy Receives CDE Review for Endometrial Cancer
Chia Tai Tianqing, a renowned biopharmaceutical company based in China, has announced that the Center...
CanSino Biologics’ 13-Valent Pneumococcal Vaccine CRM197 Accepted for NMPA Review
CanSino Biologics Inc., (HKG: 6185), a leading Chinese biopharmaceutical company, has announced that the National...
AstraZeneca’s AZD0486 Receives NMPA Greenlight for Clinical Study in B-Cell Leukemia
AstraZeneca (NASDAQ: AZN), a leading UK pharmaceutical company, has received approval from the National Medical...
BMS’s Azacitidine, First Oral AML Therapy, Reaches GBA Patients via Special Policy
Bristol-Myers Squibb (BMS, NYSE: BMY), a leading US pharmaceutical company, has announced the clinical application...
Abbisko Therapeutics Reports Positive Phase I Results for ABSK061 in Solid Tumors at ESMO TAT 2024
Shanghai-based Abbisko Therapeutics Co., Ltd. (HKG: 2256) has revealed promising outcomes from a global, multi-center...