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The approval was based on a comprehensive clinical data package, which included a single phase 1 trial and a phase 3 trial.
The approval is only for the 2.5mg tablet. The Food and Drug Administration (FDA) has approved the first generics of Xarelto ® (rivaroxaban) 2.5mg. Xarelto 2.5mg is used, in combination with ...
A study shows that high-grade glioma tumor cells harboring DNA alterations in the gene PDGFRA responded to the drug avapritinib, which is already approved by the United States Food and Drug ...
The U.S. Food and Drug Administration has approved Sanofi-Aventis's Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with diabetes mellitus.
FDA accepts Capricor's Biologics License Application for priority review, advancing deramiocel for DMD cardiomyopathy.
Perspective from Andrew A. Moshfeghi, MD, MBA The FDA approved an expanded label for Iluvien, which is now indicated for the treatment of chronic noninfectious uveitis affecting the posterior ...
Travere Therapeutics (TVTX) has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration seeking priority review ...
Encelto, the first FDA-approved treatment for MacTel, is implanted intravitreally during a surgery performed by a qualified ophthalmologist. The Food and Drug Administration (FDA) has approved ...