Millions of US adults suffering from heartburn associated with non-erosive-gastroesophageal-reflux-disease (GERD) could benefit from an impending treatment by Phathom Pharmaceuticals.
Five years after Gilead Sciences Inc. gave up on momelotinib in the wake of two phase III failures in myelofibrosis, the JAK1/2 and ACVR1 inhibitor has found its way to the market in the hands of GSK plc. Branded Ojjaara, the drug gained U.S. FDA approval for use in intermediate- or high-risk myelofibrosis patients with anemia regardless of prior administration with JAK inhibitors such as Jakafi (ruxolitinib, Incyte Corp.). The approval came a day before the Sept. 16 PDUFA date, which had been extended by three months in June to allow the agency to review recently submitted data. A rare blood cancer characterized by dysregulated JAK-signal transducer and resulting in splenomegaly and progressive anemia, myelofibrosis affects roughly 25,000 people in the U.S.
PDUFA target action date set to occur by December 8, 2023
NEW YORK, June 6, 2023 /PRNewswire/ BrainStorm Cell Therapeutics Inc. , a leading developer of adult stem cell therapeutics for. | June 6, 2023
FDA Extending PDUFA Date by Three Months to Allow More Time to Complete Their Review; New PDUFA Date Set to November 27, 2023STAMFORD, Conn., June 05, 2023 SpringWorks Therapeutics, Inc. , a. | June 5, 2023