TEL-AVIV, Israel and RALEIGH, N.C. , Aug. 21, 2019 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL ) ( Tel-Aviv Stock Exchange : RDHL ) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of clinical late-stage, ...
Key Highlights and Upcoming Milestones: U.S. FDA acceptance of the New Drug Application (NDA) for Talicia ® for H. pylori for priority review and assignment of a target PDUFA action date of November 2, 2019 Preparations ongoing for the potential U.S. ...
TEL-AVIV, Israel and RALEIGH, N.C. , July 15, 2019 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL ) ( Tel-Aviv Stock Exchange : RDHL ) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of clinical late-stage, ...
U.S. FDA accepts NDA for priority review PDUFA date set for November 2, 2019 H. pylori infection affects approximately 35% of the U.S. population and is the strongest risk factor for the development of gastric cancer and a major risk factor for peptic ulcer disease and MALT lymphoma TEL-AVIV, ...
The new patent expands the robust patent portfolio covering RHB-104 and RHB-204 RedHill plans to initiate a pivotal Phase 3 study with RHB-204 for the treatment of pulmonary nontuberculous mycobacteria (NTM) infections in the second half of 2019 RedHill plans to meet with the FDA in the second ...
TEL-AVIV, Israel and RALEIGH, N.C. , May 28, 2019 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL ) ( Tel-Aviv Stock Exchange : RDHL ) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on gastrointestinal diseases, today announced the appointment of Dr. ...
TEL-AVIV, Israel and RALEIGH, N.C. , May 23, 2019 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL ) ( Tel-Aviv Stock Exchange : RDHL ) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on gastrointestinal (GI) diseases, today announced that Mr. ...
Rob Jackson joins as Vice President of Marketing Robert J. Gilkin, Jr. joins as Vice President of Market Access Steven Thomasian to join as Vice President of Supply Chain TEL-AVIV, Israel and RALEIGH, N.C. , May 21, 2019 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. ...
Key Highlights and Upcoming Milestones: NDA submitted to the FDA for Talicia ® for H. pylori infection, with potential U.S. commercial launch in Q4/2019, assuming FDA approval FDA meeting planned for H2/2019 to discuss design of confirmatory Phase 3 study and path to potential approval for RHB-104 ...
The NDA follows a recent positive pre-NDA meeting with the FDA The NDA for Talicia ® is eligible for six-month priority review Talicia ® is eligible for a total of eight years of U.S. market exclusivity, in addition to patent protection until at least 2034 RedHill continues to strengthen its ...
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