Drug previously rejected by regulators gets green light and is set to launch later this year
Ardelyx Inc. ARDX, -0.58% on Tuesday won its long fight for U.S. regulatory approval of a treatment designed to help patients with chronic kidney disease.
More than 550,000 people in the U.S. have chronic kidney disease and are on maintenance dialysis. The vast majority of them have high phosphorus levels, also called hyperphosphatemia, according to Ardelyx. The FDA approved Xphozah as add-on therapy in patients who can’t tolerate or have an inadequate response to phosphate binders, Ardelyx said in a release.
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
New drug for IBD, ulcerative colitis wins FDA approval: 'Amazing results'This Week's Health Headlines: Bionic woman, Sex life hacks, & Deadly “superbug”
Read more »
Watch 'Last Week Tonight' Address Food Concerns at the FDAThe FDA lacks regulation, manpower, and inspection directives, and this costs Americans' health and wellbeing.
Read more »
FDA faces pressure to act nationwide on red dye in foodRed No. 3 was banned from cosmetics three decades ago. Consumer advocates question why it's still allowed in food products, including many popular with kids.
Read more »
FDA Approves Merck's Keytruda to Treat Lung CancerThe U.S. Food and Drug Administration on Monday approved the expanded use of Merck & Co's blockbuster immunotherapy Keytruda in early-stage patients with non-small cell lung cancer who can get their tumors removed surgically. The U.S. health regulator's approval extends...
Read more »
FDA may soon ban some chemical hair-straightening products over cancer riskChemical hair straighteners or “relaxers,' which are often marketed to Black women, have been linked to a number of short-term and long-term health risks, including uterine cancer.
Read more »