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...
Drug
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...
Sanofi Halts Development of Tusamitamab Ravtansine After Missed Trial Endpoints
Sanofi (NASDAQ: SNY) has announced the discontinuation of its antibody-drug conjugate (ADC) tusamitamab ravtansine following...
Asieris Pharmaceuticals Gets Australian Greenlight for Acinetobacter Infection Drug Trial
Asieris Pharmaceuticals (SHA: 688176), a China-based specialist in urogenital cancer treatments, has received approval in...
Sino Biopharmaceutical Completes Enrollment for Phase III Trial of Anlotinib in Soft Tissue Sarcoma
Sino Biopharmaceutical Ltd (HKG: 1177), a China-based pharmaceutical giant, has announced the completion of patient...
Jiangsu Nhwa Pharmaceutical Gets NMPA Green Light for Schizophrenia Drug Trial
Jiangsu Nhwa Pharmaceutical Co., Ltd. (SHE: 002262), a China-based pharmaceutical company, has announced that it...
Legend Biotech’s Carvykti Therapy to Include Myeloid Neoplasms Warning in Label Update
GenScript Biotech Corporation (HKG: 1548), a China-based Contract Research Organization (CRO), has announced that its...
Takeda’s Livtencity Receives NMPA Approval, a First in China for CMV Infection Treatment
Japanese pharmaceutical company Takeda (TYO: 4502) has received its first market approval from China’s National...
AstraZeneca Advances to Phase III with PD-1xTIGIT BsAb for Biliary Tract Cancer
AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, is set to initiate a Phase III...
Lee’s Pharmaceutical’s Socazolimab Becomes China’s First PD-L1 mAb for Cervical Cancer
Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has secured in-licensed rights for socazolimab, a treatment for...
FDA Rejects MSD’s Gefapixant for Chronic Cough Treatment Over Efficacy Concerns
The US Food and Drug Administration (FDA) has declined to approve a filing from Merck,...