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,...
Drug
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...
GeneQuantum Healthcare’s GQ1005 ADC Receives CDE Clearance for Phase III Breast Cancer Trial
SUZHOU—GeneQuantum Healthcare (Suzhou) Co., Ltd has received clearance from the Center for Drug Evaluation (CDE)...
Sinocelltech’s Anti-Angiogenic Biologic SCT520FF Gets NMPA Green Light for Neovascular AMD Clinical Study
SHANGHAI—Sinocelltech Group Ltd (SHA: 688520), a Chinese biopharmaceutical company, has announced that it has received...
China’s Evopoint Biosciences and UK’s GSK Eye Breakthrough Therapy Designations for Cancer Therapies
BEIJING/LONDON—The Center for Drug Evaluation (CDE) in China has indicated that Evopoint Biosciences’ EZH2 inhibitor...
Shandong Buchang Pharmaceuticals’ rhEPO-Fc for CKD Anemia Accepted for Review by China’s CDE
BEIJING—The Center for Drug Evaluation (CDE) in China has accepted the market filing for a...
Biocon Biologics Resolves Patent Dispute with J&J, Secures Market Entry for Biosimilar Stelara
Biocon Biologics Ltd, the biosimilars division of Indian pharmaceutical company Biocon Ltd (BOM: 532523, NSE:...
Zuellig Pharma Partners with Regeneron for Libtayo Launch in South Korea and Taiwan
Singapore-headquartered Zuellig Pharma, a leading healthcare solutions provider, has entered into an agreement with US...
HutchMed Halts China Filing for Gastric Cancer Drug Fruquintinib Following Regulatory Feedback
HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013), a China-based biopharmaceutical company, has announced the withdrawal...
Novo Nordisk to Resubmit Wegovy Heart Failure Application with Updated Clinical Data
Denmark’s pharmaceutical giant, Novo Nordisk (NYSE: NVO), has reported significant findings on the efficacy of...
AccurEdit Therapeutics’ Gene-Editing Drug ART001 Clears FDA Hurdle for US Clinical Trials
SUZHOU—AccurEdit Therapeutics (Suzhou) Co., Ltd, a leading Chinese specialist in gene editing therapies, has announced...
Bio-Thera Solutions’ BAT2406 Biosimilar Gets Green Light for Clinical Trials in China
GUANGZHOU—Bio-Thera Solutions (SHA: 688177), a leading biopharmaceutical company based in Guangzhou, has received approval from...