Xian Janssen’s Tremfya Heads for Priority Review in China for Crohn’s Disease Treatment
The Center for Drug Evaluation (CDE) has indicated that Xian Janssen Pharmaceutical’s Tremfya (guselkumab), an...
Drug
EMA Reviews J&J’s Darzalex Subcutaneous Formulation for Newly Diagnosed Multiple Myeloma
The European Medicines Agency (EMA) has this week received an indication extension filing from Johnson...
Gilead and MSD Report Positive Interim Data for Once-Weekly HIV Treatment in Phase II Trial
Gilead Sciences Inc. (NASDAQ: GILD) and Merck & Co., Inc., known as MSD (NYSE: MRK),...
Henlius Biotech’s HER2 Targeting Biosimilar Secures Thai and Philippine Approvals
Shanghai Henlius Biotech Inc., (HKG: 2696) a leading China-based biotech firm, has announced that its...
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...
Formosa Pharmaceuticals Secures FDA Nod for New Steroidal Eye Drug, Set to Launch via Eyenovia
Taiwan-based Formosa Pharmaceuticals (TPE: 6838) has received approval from the US Food and Drug Administration...
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...
Novo Nordisk’s Ozempic Meets Phase III Endpoints in Type 2 Diabetes and Chronic Kidney Disease Study
Novo Nordisk (NYSE: NVO), a Denmark-based pharmaceutical company, has this week published results from a...
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...
Hybio Pharmaceutical Gets FDA Nod for Liraglutide Raw Materials with DMF Adequacy Letter
Hybio Pharmaceutical Co., Ltd (SHE: 300199), a China-based pharmaceutical company, has announced that it has...
Shanghai RAAS Receives NMPA Approval to Initiate Clinical Trial for Hemophilia Preventive Treatment
Shanghai RAAS (SHE: 002252), a biopharmaceutical company based in China, has announced that it has...
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...
Pfizer’s Cibinqo Secures NMPA Approval for Expanded Use in Atopic Dermatitis
The National Medical Products Administration (NMPA) has released drug approval certificate delivery information that points...
Novartis Gene Therapy Zolgensma Shows Continued Benefits in Broader SMA Patient Group
Swiss pharmaceutical giant Novartis (NYSE: NVS) has presented Phase III data this week, demonstrating that...
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...
Aosaikang’s Marketing Approval Filing for Delafloxacin Accepted by China’s NMPA
Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755), a Chinese pharmaceutical company, has announced that the...
Huadong Medicine’s Arcalyst Filing for Recurrent Pericarditis Accepted by China’s NMPA
Huadong Medicine Co., Ltd, (SHE: 000963) a Chinese pharmaceutical company, has announced that the National...
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...
HitGen Secures CDE Approval for Lipisense IND Filing, Advancing Development for Dyslipidemia Treatment
HitGen Inc., (SHA: 688222) a China-based pharmaceutical company, has announced that the Investigational New Drug...