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...
Drug
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...
Humanwell Healthcare’s Innovative Drug for Solid Tumors Gets Green Light from NMPA
Humanwell Healthcare (Group) Co., Ltd (SHA: 600079), a leading pharmaceutical entity in China, has received...
Jiangsu Hengrui and Chongqing Genrix Launch Anti-IL-17 Therapies for Psoriasis in China
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) and Chongqing Genrix Biopharmaceutical Co., Ltd, two leading...
Sanofi’s Tolebrutinib Shows Mixed Results in Phase III Multiple Sclerosis Trials
PARIS—French pharmaceutical giant Sanofi (NASDAQ: SNY) has reported mixed outcomes from three Phase III trials...
Bayer’s Finerenone Shows Promise in Heart Failure Treatment, Outperforms Placebo in Phase III Trial
FRANKFURT—Bayer AG (FRA: BAYN) has announced positive results from the Phase III FINEARTS-HF study for...
Henlius Biotech’s HLX17 Biosimilar to MSD’s Keytruda Wins NMPA Clinical Trial Approval
SHANGHAI—Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that it has received clinical trial approval...
Jiangsu Simcere’s Edaravone, Borneol Sublingual Tablet Earns FDA Breakthrough Therapy Designation for Stroke Treatment
HONG KONG—Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that it has received Breakthrough...