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AP Pharma (APPA.OB) announced that it has resubmitted its New Drug Application (NDA) to the FDA for its lead product candidate, APF530, for the prevention of acute and delayed onset chemotherapy-induced nausea and vomiting (CINV). A.P. Pharma expects to be notified that the FDA has accepted the refiling and has established a Prescription Drug User Fee Act (PDUFA) goal date within the next 60 days or so.
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A.P. Pharma, Inc. (NASDAQ:APPA), a specialty pharmaceutical company, announced today positive results from its pivotal Phase 3 study comparing te efficacy of APF530 (the Company's proprietary, sustained release formulation of granis... Read Post
A.P. Pharma, Inc. (Nasdaq:APPA), a specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for APF530 for the potential treatment of chemoth... Read Post
A.P. Pharma, Inc. (Nasdaq:APPA), a specialty pharmaceutical company, announced that it has submitted a New Drug Application (NDA) for its lead product, APF530, to the U.S. Food and Drug Administration (FDA). Read Post