FDA's NDA And BLA Approvals: Nipride RTU
Original new drugs and biologics recently approved by US FDA.
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Serenity's Noctiva and Ferring's Nocdurna both use desmopressin to treat nocturia, but Nocdurna has racked up three complete response letters while Noctiva was approved on the first try. US FDA explains how trial design and secondary endpoints influenced its decision in its denial of a Ferring citizen petition.
Keeping Track: Xermelo, Odactra, Noctiva Approved; Second Submissions For Avelumab And Deutetrabenazine
The latest drug development news and highlights from our US FDA Performance Tracker.
The company is optimistic about a significant portion of eligible patients opting for its newly approved long-acting HIV therapy over daily, oral antiviral therapy.