AbbVie’s EPKINLY gains FDA nod for relapsed follicular lymphoma, offering new hope for patients
The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study
The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 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
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