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Janssen Research & Development announced the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for XARELTO (rivaroxaban) to include a 10 mg once-daily dose for reducing the risk of VTE after at
Under the circumstances of a huge number of applied varieties and limited review resources, obtaining the right for priority review of enterprises’ pharmaceutical product applications can certainly largely reduce...
The US Food and Drug Administration (FDA) has accepted priority review for EMD Serono's biologics licence application (BLA) for avelumab to treat patients with locally advanced or metastatic urothelial carcinoma (mUC).
US regulators have agreed to undertake a speedy review of Pfizer's experimental drug inotuzumab ozogamicin as a treatment for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Bayer announced that the U.S. Food and Drug Administration (FDA) has granted priority review designation to the supplemental New Drug Application (sNDA) for regorafenib.