Duality Biologics’ DB-1303 on Track for Breakthrough Designation for HER2+ Endometrial Cancer
The Center for Drug Evaluation (CDE) website has indicated that DB-1303, a HER2 targeted antibody...
Cancer
Bayer Posts 1.2% YOY Sales Decline in 2023 with Pharmaceuticals and Consumer Health Segment Updates
Germany’s Bayer (ETR: BAYN) has released its financial results for 2023, marking a year of...
Sandoz Achieves FDA Milestone with Approval of First US Denosumab Biosimilars
The US Food and Drug Administration (FDA) has granted Sandoz (SWX: SDZ), a Switzerland-based pharmaceutical...
Bio-Thera Solutions Receives NMPA Approval for Three Cancer Treatments Including a Novel ADC
Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, has received separate clinical trial approvals...
EMA Reviews Datopotamab Deruxtecan Filings from AstraZeneca and Daiichi Sankyo for Oncology Indications
The European Medicines Agency (EMA) has accepted for review two oncology filings for the antibody-drug...
Luye Pharma Initiates Phase III Clinical Trial for Irinotecan Liposome Injection in Small-Cell Lung Cancer
Luye Pharma Group (HKG: 2186), a China-based pharmaceutical company, has announced the enrollment of the...
Hengrui Pharmaceuticals Gets NMPA Green Light for KRAS G12C Inhibitor Clinical Trial in Advanced Solid Tumors
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has received approval from the National Medical Products...
Innovent Biologics’ Taletrectinib Receives Second NDA Acceptance in China for ROS1 Positive NSCLC
Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced that the...
BeiGene’s Brukinsa Outperforms Acalabrutinib in MAIC for Relapsed/Refractory CLL, Says BeiGene
BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the results of a matching-adjusted...
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...
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)...
Haihe Pharmaceuticals Licenses Glumetinib to Taiho for Exclusive Development in Japan and Asia
Shanghai Haihe Pharmaceutical Co., Ltd has entered into a licensing agreement with Taiho Pharmaceutical Co.,...
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...
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...
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...
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...
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...