Achieve Life Sciences announced the successful topline results from the New Zealand RAUORA Phase III non-inferiority clinical trial comparing cytisinicline to Chantix (varenicline) in Maori (indigenous New Zealanders)… read more.
RedHill Biopharma Ltd. announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the Company’s Clinical Trial Authorization application to commence a Phase II/III study… read more.
Heron Therapeutics, Inc. announced that it received a Complete Response Letter (CRL) from the FDA on June 26, 2020 regarding its New Drug Application (NDA) for HTX 011… read more.
Intercept Pharmaceuticals, Inc. announced that the FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of… read more.
Cancer Prevention Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA seeking accelerated approval for CPP 1X/sul for treatment of adults with familial adenomatous polyposis (FAP)…. read more.
Kiniksa Pharmaceuticals announced that the Phase III RHAPSODY trial showed that rilonacept achieved its primary and all major secondary efficacy endpoints in patients with recurrent pericarditis. Results show… read more.
Iterum Therapeutics announced topline results from its phase III SURE 1 clinical trial of sulopenem for the treatment of Uncomplicated Urinary Tract Infections (uUTI). Sulopenem is a novel… read more.
Alexion Pharmaceuticals announced that the European Commission has approved Ultomiris (ravulizumab)—the first and only long-acting C5 complement inhibitor administered every eight weeks*—for the treatment of adults and children… read more.
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