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14475 Articles
Policy / Regulatory

China’s 9th National VBP Tender Round Targets CNS Drugs and Includes Oncology Therapies

Policy / Regulatory

NMPA Revises Drug Conditional Approval Procedures: Streamlined Processes and Requirements

CompanyDeals

GenFleet Therapeutics and Verastem Oncology Ink Licensing Deal for RAS Pathway Cancer Therapies

CompanyDrug

Boehringer Ingelheim Submits Three INDs for Survodutide Phase III Trials in China

Company

Harbour BioMed Reports First Profitable Half-Year in H1 2023 Financial Results

CompanyMedical Device

Allurion’s Non-Invasive Weight-Loss Balloon Debuts at Ruijin Hospital’s Hainan Subsidiary

CompanyDrug

Janssen Submits Rybrevant for FDA Review as First-Line NSCLC Treatment

CompanyPolicy / Regulatory

AstraZeneca Challenges US Government’s Drug Price Negotiation Plan for Medicare

CompanyDrug

MSD Initiates Phase III Trial for PCSK9 Inhibitor MK-0616 in LDL Cholesterol Reduction

CompanyDeals

Henlius Biotech Expands Licensing Agreement with KGbio for PD-1 Inhibitor

CompanyDrug

Sandoz Receives FDA Clearance for First Biosimilar to Biogen’s Tysabri

Policy / Regulatory

CDE Seeks Public Feedback on Biological Product Changes During Clinical Trials