FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer
HER2-mutant NSCLC typically has a poor prognosis and limited treatment options
HER2-mutant NSCLC typically has a poor prognosis and limited treatment options
The EIR follows a product-specific Pre-Approval Inspection from September 1 to September 5, 2025.
A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations
New test expands access to early Alzheimer’s assessment, streamlining diagnostic pathways and improving referral efficiency
Lupin's partnership program is designed to foster collaborations with companies looking to extend their product lifecycles
Rifaximin tablets are a rifamycin antibacterial indicated for reducing the risk of overt hepatic encephalopathy
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