Tags : Inrebic

Insights+: The US FDA New Drug Approvals in August 2019

The US FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 31 new products so far in 2019. In 2018 FDA approved 59 novel products including 42 New Chemical Entity and 17 Biologics while breaking its past year’s records of approval. However, there is a significant […]Read More

Celgene’s Inrebic (fedratinib) Receives the US FDA’s Approval for Myelofibrosis

Shots: The approval is based on multiple studies including JAKARTA and JAKARTA2. The P-III JAKARTA study involves assessing of Inrebic (400mg) vs PBO in patients with intermediate-2 or high-risk, primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with splenomegaly and a platelet count of ≥50 x 109/L2 prior not treated with JAK inhibitor The […]Read More