The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping
The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research
Syngene will also build and operate a new dedicated drug development laboratory to accelerate the advancement of Amgen R&D projects
It is the first approved generic and is eligible for 180 days of Competitive Generic Therapy exclusivity
Orencia is the first FDA-approved therapy to prevent acute graft versus host disease following hematopoietic stem cell transplant
Deplesin is an add-on therapy to gold standard agents like lithium, valproic acid, and carbamazepine, supporting patients in ways that prescription medications often cannot
Collaboration aims to develop innovative machine learning and artificial intelligence solutions for personalized and earlier treatment in neurology
Intox is a GLP certified pre-clinical contract research organization with its test facilities in Pune
FDA changes inspection classification of the facility to Voluntary Action Indicated
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