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Novartis snaps up Priority Review Voucher for $130m
December 19, 2017Novartis has got its wallet out to pick up a Priority Review Voucher (PRV) from Ultragenyx, forking out $130 million as part of the trade. -
FDA Grants Priority Review of 10 mg XARELTO to Reduce VTE Risk
June 29, 2017Janssen 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 -
Which Pharmaceutical Products Have Entered Priority Review? What are the Conditions Required to Ente
April 28, 2017Under 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... -
US FDA accepts priority review for EMD Serono's application for avelumab
March 02, 2017The 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). -
Priority review for Pfizer’s ALL drug
February 23, 2017US 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). -
Regorafenib granted priority review in the U.S. for second-line treatment of liver cancer
February 08, 2017Bayer announced that the U.S. Food and Drug Administration (FDA) has granted priority review designation to the supplemental New Drug Application (sNDA) for regorafenib.
Pharma Sources Insight January 2025
