AstraZeneca and Daiichi Sankyo’s Dato-DXd Misses Overall Survival Endpoint but Shows Promise in NSCLC Subgroup
AstraZeneca (NASDAQ: AZN) and its co-development partner, Japan’s Daiichi Sankyo, have released data from the...
Drug
Vcanbio’s Stem Cell Therapy VUM02 Gets NMPA Approval for Systemic Sclerosis Clinical Trial
Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645), a biotechnology company based in China,...
Innovent Biologics’ Dupert Demonstrates Positive Results in Phase II NSCLC Trial
Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that...
China’s CDE Issues Draft Guidelines for Biosimilar Pharmaceutical Similarity Research
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has released...
Zelgen Biopharma’s ZG006 Shows Promising Anti-Tumor Efficacy in Phase I/II SCLC Study
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced...
Merck and Daiichi Sankyo’s Ifinatamab Deruxtecan Shows Promising Results in Phase II ES-SCLC Trial
Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK), a leading U.S. pharmaceutical company, and its...
China’s CDE Releases 86th Batch of Reference Preparations for Generic Drug Evaluation
China’s Center for Drug Evaluation (CDE) has unveiled its 86th roster of reference preparations for...
Akeso’s Ivonescimab Shows Promising Results in Phase III Clinical Trial for Hepatocellular Carcinoma
Akeso Inc. (HKG: 9926), a biopharmaceutical company based in China, has announced that its first-in-class...
Sinocelltech’s Herpes Zoster Vaccine SCTV04C Clears NMPA for Clinical Trial
Sinocelltech Group Ltd (SHA: 688520), a biopharmaceutical company based in China, has received approval from...
Jiangsu Kanion Pharmaceutical Gets NMPA Go-Ahead for Psoriasis Drug Clinical Trial
Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557), a prominent pharmaceutical company based in China, has...
Viatris Launches First-of-Its-Kind Nasal Spray Dymista in China for Allergic Rhinitis
Viatris Inc. (NASDAQ: VTRS), a leading global pharmaceutical company based in the U.S., has announced...
Novo Nordisk Advances in China with Submission of Sogroya for Adult Growth Hormone Deficiency
Denmark’s pharmaceutical heavyweight, Novo Nordisk (NYSE: NVO), has reached a significant milestone with the National...
Kelun-Biotech’s ADC for Cancer Gets NMPA Review, Expands MSD Collaboration
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has achieved a regulatory milestone with its clinical...
Roche’s Columvi for Relapsed DLBCL Gets Review Nod from China’s CDE for New Indication
The Center for Drug Evaluation (CDE) in China has accepted for review an additional indication...
Jiangsu Hengrui’s Ivarmacitinib for Adult Alopecia Areata Accepted for Review by China’s CDE
The Center for Drug Evaluation (CDE) has given the green light for the review of...
Hanx Biopharmaceuticals Receives NMPA Approval for HX009 Combination Therapy Phase II Trial
On September 5, 2024, China-based Hanx Biopharmaceuticals Co., Ltd announced that it has received approval...
European Commission Approves Merck’s Keytruda-Padcev Combo for First-Line Urothelial Carcinoma Treatment
Merck & Co., Inc. (NYSE: MRK), a global healthcare leader based in the United States,...
Manufacturing Challenges for Novo Nordisk’s Ozempic Impact Diabetes and Obesity Treatments in Europe
Novo Nordisk (NYSE: NVO), a leading Danish pharmaceutical company, has released a joint statement with...
Skyline Therapeutics’ Gene Therapy Receives FDA Orphan Drug Designation for Retinitis Pigmentosa Treatment
Skyline Therapeutics, a biopharmaceutical company based in China, has received Orphan Drug Designation (ODD) from...
Innovent Biologics’ IBI363 Earns FDA Fast-Track Designation for Advanced Melanoma Treatment
Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has received fast-track...