Drug Approval | April 12, 2025
FDA approves Opdivo plus Yervoy as treatment metastatic colorectal cancer
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
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Protein-bound Paclitaxel is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and metastatic adenocarcinoma of the pancreas
Jobevne is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis
Raichur site is the group’s largest API facility and part of a wider network of seven sites
The company expects to launch this product through its marketing partner in the near future
The IND application supports the next phase of development of SBO-154
The inspection has concluded with four observations
Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy
Abbott's investigational Coronary Intravascular Lithotripsy (IVL) System offers a new potential treatment by using sound pressure waves to treat arterial calcium blockages
Alembic Pharmaceuticals successfully completes USFDA inspection for API-III facility
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