FDA Prioritizes Roche’s Xolair for Food Allergy Indication Extension Ahead of Q1 Decision
The U.S. Food and Drug Administration (FDA) has prioritized Roche’s (SWX: ROG) indication extension filing...
Drug
Lepu Biotechnology Completes Enrollment for Phase IIb Trial of MRG003 in Nasopharyngeal Carcinoma
Lepu Biotechnology Co., Ltd (HKG: 2157), based in China, has announced the completion of subject...
Shanghai Henlius Secures Indonesian Approval for HanSiZhuang in Small-Cell Lung Cancer
Shanghai Henlius Biotech Inc. (HKG: 2696) has received market approval from the Indonesian Food and...
Clover Biopharma’s SCB-219M Shows Promising Phase I Results for Chemotherapy-Induced Thrombocytopenia
Clover Biopharmaceuticals Ltd (HKG: 2197), based in China, has announced promising preliminary results from its...
Fosun’s HLX42 Receives Fast-Track Designation from FDA for NSCLC Treatment
Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196; SHA: 600196) has announced that its antibody-drug conjugate...
Simcere Secures Approval for Local Manufacturing of Cosela, Boosting Patient Access
China-based Simcere Pharmaceutical Group (HKG: 2096) has received supplementary filing approval for its drug Cosela...
Sanofi Gains NMPA Approval for Innovative Rosuvastatin and Ezetimibe Combination Therapy
Sanofi (NASDAQ: SNY), the French pharmaceutical giant, has announced that it has received market approval...
AstraZeneca Secures FDA Approval for Self-Administered hATTR-PN Therapy Wainua
AstraZeneca (AZ, NASDAQ: AZN), headquartered in the UK, announced last week that the U.S. Food...
Taiwan FDA Reviews Nefecon New Drug Application from Everest Medicines
China-based Everest Medicines (HKG: 1952) has announced that the New Drug Application (NDA) for Nefecon...
Amgen’s Lumakras Faces Full Approval Delay as FDA Requests New Study
The US Food and Drug Administration (FDA) has declined to grant full approval for Amgen’s...
Guangdong Zhongsheng Pharmaceutical’s ZSP1273 for Influenza A Accepted for Review by NMPA
Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a Chinese pharmaceutical company, has announced that China’s...
Konruns Pharmaceutical Receives NMPA Go-Ahead for KC1036 Esophageal Cancer Study
Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has received approval from the National Medical Products...
Simcere Affiliate Shanghai Simnova Biotech Gets China Nod for CAR-T Therapy SNC109
Shanghai Simnova Biotech Co., Ltd, known as Simnova outside of China and an affiliate of...
FDA Grants Priority Review to MSD and Daiichi Sankyo’s ADC for Lung Cancer
The US Food and Drug Administration (FDA) has accepted under priority review a filing from...
AbbVie and Alpine Immune Sciences Halt Early Enrollment in Lupus Trial
AbbVie (NYSE: ABBV) and Alpine Immune Sciences (SWX: ALPN) have made the decision to prematurely...
J&J’s Rybrevant-Lazertinib Combo Accepted for FDA Review in NSCLC
The US Food and Drug Administration (FDA) has accepted for review Johnson & Johnson’s (J&J;...
Shanghai Fosun to Exclusively Commercialize Generic Entresto in China
Nanjing F&S Pharmatech Co., Ltd has officially launched its generic version of Novartis’s heart failure...
Shouyao Holdings Receives Ethical Approval for Phase III Study of ALK Inhibitor SY-3505
Beijing-based Shouyao Holdings (Beijing) Co., Ltd (SHA: 688197) has announced that it has received ethical...
Jiangxi Jemincare Group Secures Clinical Trial Approvals for Six Drugs in China and the US
China-based Jiangxi Jemincare Group (SHA: 603222) has announced receiving clinical trial approvals for six of...
Yifan Pharmaceutical’s F-652 Shows Promise in Phase II Clinical Trial for ACLF
Yifan Pharmaceutical Co., Ltd (SHE: 002019), a China-based pharmaceutical company, has reported positive outcomes from...