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The RHB-103 New Drug Application (NDA) for marketing approval in the U.S. is subject to a standard 10-month review period and will have a Prescription Drug User Fee Act (PDUFA) action date...
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The open label Phase IIa study is designed to assess the efficacy and safety of RHB-104 in Multiple Sclerosis (MS) patients. The study follows successful completion of 4 pre-clinical...
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Following the prior successful completion of four pharmacokinetic (PK) clinical studies, the Company held a Type B meeting regarding RHB-101 with the U.S. Food and Drug Administration (FDA)...
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TEL-AVIV, Israel, May 28, 2013 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the...
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The Company Maintains a Strong Balance Sheet Following Submission to the FDA of Its First New Drug Application (NDA) for RHB-103 (Migraine) RedHill Plans to Submit a Second NDA, for RHB-102...
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TEL-AVIV, Israel, March 27, 2013 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily on...
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The Company held a Scientific Advice meeting regarding RHB-101 with the Danish Health and Medicines Authority (DKMA) Following the positive results of the meeting, the Company intends to...
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TEL-AVIV, Israel, March 6, 2013 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily on...
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Following a successful comparative bioavailability trial, the Company met with the FDA to discuss its planned New Drug Application (NDA) filing for RHB-102 Company plans to file the RHB-102...
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Key Planned Milestones for 2013 Include Commencement of Phase III and Phase II/III Studies With RHB-104 (Crohn's Disease) and RHB-105 (H. pylori), Respectively, and New Drug Application (NDA)...