CDE Lists Five Drugs and One Companion Diagnostic for Priority Review Status
The Center for Drug Evaluation (CDE) has indicated on its website that five investigational drugs...
Drug
Frontera Therapeutics Receives FDA Approval for Phase II Study of First Chinese rAAV Gene Therapy
Frontera Therapeutics, Inc., a Sino-US biopharmaceutical company, has announced that it has received approval from...
Sanofi’s Sarclisa Secures FDA Approval for First-Line Multiple Myeloma Treatment
Sanofi (EPA: SAN; NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA)...
Novo Nordisk’s Obesity Drug Monlunabant Phase IIa Results Lead to Share Price Drop
Novo Nordisk (NYSE: NVO), a Danish pharmaceutical company, has reported Phase IIa trial results for...
Sichuan Biokin’s Multi-Specific Antibody GNC-077 Gets NMPA Nod for Advanced Solid Tumor Clinical Trial
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a biopharmaceutical company based in China, has announced...
SciClone Pharmaceuticals Gets NMPA Approval for Phase III Study of First-in-Class SERD Orserdu
SciClone Pharmaceuticals Inc. (HKG: 6600), a Chinese pharmaceutical company, has received approval from the National...
ApolloBio’s HPV Therapeutic Vaccine VGX-3100 Gets NMPA Green Light for Clinical Trial
ApolloBio Corp., a joint stock company of China’s leading cephalosporin manufacturer Jincheng Pharmaceutical Group Co.,...
Jacobio Pharma’s Pan-KRAS Inhibitor JAB-23E73 Clears FDA Hurdle for Clinical Trials
Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, has received the green light...
Hybribio’s Chloroquine Phosphate Gel Cleared for Clinical Trial on High-Risk HPV Infections
Hybribio Limited (SHE: 300639), a Guangdong-based pharmaceutical company, has received approval from the National Medical...
Ocumension Therapeutics’ OT-502 Receives NMPA Acceptance for Post-Cataract Inflammation Treatment
Ocumension Therapeutics (HKG: 1477) announced on September 23, 2024, that the National Medical Products Administration...
Yantai Dongcheng Pharmaceutical’s 18F-LNC1007 Receives Clinical Clearance for Solid Tumor Diagnostics
Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has received clinical...
Fosun Pharmaceutical’s PD-1 Inhibitor HanSiZhuang Recommended for Approval by EMA’s CHMP
Shanghai Fosun Pharmaceutical Group Co., Ltd (SHA: 600196; HKG: 2196), a leading pharmaceutical company in...
AstraZeneca’s HIMALAYA Trial Data Showcases Significant Survival Benefits for Liver Cancer Treatment at ESMO 2024
At the European Society for Medical Oncology (ESMO) 2024 conference, AstraZeneca (NASDAQ: AZN, LON: AZN)...
Aligos Therapeutics’ ALG-055009 Achieves Positive Topline Results in Phase 2a HERALD Study for MASH
Aligos Therapeutics, a clinical-stage biopharmaceutical company focused on liver and viral diseases, has announced positive...
Roche’s Xofluza Receives FDA Approval for Reducing Influenza Transmission in Phase III Study
Roche (SWX: ROG; OTCMKTS: RHHBY) has announced that its antiviral drug Xofluza (baloxavir marboxil) has...
J&J’s Rybrevant Secures FDA Approval for EGFR/c-MET Non-Small Cell Lung Cancer Treatment
Johnson & Johnson (J&J; NYSE: JNJ)has announced that the US Food and Drug Administration (FDA)...
Beijing’s Apollobio Receives NMPA Approval for HPV Therapeutic Vaccine VGX-3100
Beijing’s Apollobio, has announced that the National Medical Products Administration (NMPA) has granted market approval...
Insilico Medicine’s AI-Generated Drug Candidate ISM001-055 Shows Positive Phase II Results in IPF Study
China-based artificial intelligence (AI) drug developer Insilico Medicine has reported initial positive data from its...
Lee’s Pharmaceutical’s Zhaoke Ophthalmology Receives NMPA Approval for Generic Lumigan
Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has...
Jiangsu Hengrui Pharmaceuticals’ SHR-1701 Combo Therapy for Gastric Cancer Accepted for Review by China’s NMPA
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced...