Drug Approval | August 12, 2025
Boehringer’s lung cancer medicine gets FDA approval
FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC
FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC
Longer-term follow up in the FLAURA2 Phase III trial confirms the favourable benefit-risk profile of this combination
ART-123 is a recombinant human thrombomodulin approved in Japan in 2008
First and only TROP2-directed therapy approved in the US for the treatment of lung cancer
The newly launched protocol will accelerate the clinical development of stenoparib and its drug-specific Drug Response Predictor (DRP) companion diagnostic (CDx) toward potential FDA approval
The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance
Integrated facility to deliver end-to-end, customized workflows across life sciences, diagnostics, and applied markets
Alembic Pharmaceuticals commissions new facility at Pithampur
The first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma
Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years
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