FDA approves Roche’s kidney inflammation drug
Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study
Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study
Proposed acquisition adds petosemtamab, a late-stage asset with two Breakthrough Therapy Designations, to Genmab’s portfolio
Hengrui is eligible to receive regulatory and commercial milestone payments of up to US$1.093 billion
FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC
First and only TROP2-directed therapy approved in the US for the treatment of lung cancer
This is specifically for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved
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