NEWTON, Mass. – Alcresta Therapeutics, Inc., a leading commercial-stage company focused on developing and commercializing novel enzyme-based products, today announced publication of a position paper by the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) Pancreas Committee recommending the use of RELiZORB® (immobilized lipase cartridge), a first-of-its-kind digestive...
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LEXINGTON, Mass. — Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the European Medicines Agency (EMA) has granted Orphan Designation for ADX-2191 (methotrexate intravitreal injection, USP) for the treatment of primary large B-Cell lymphomas of immune-privileged sites, including primary vitreoretinal lymphoma. There is currently no approved treatment for patients with...
LEXINGTON, Mass. – Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company for ADX-2191 (methotrexate for intravitreal injection) for the treatment of primary vitreoretinal lymphoma (PVRL). There are no approved treatments for PVRL, a rare, aggressive,...
LEXINGTON, Mass. — Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced receipt of a Special Protocol Assessment Agreement Letter from the U.S. Food and Drug Administration (FDA) for ADX-2191 (methotrexate injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma (PVRL), a rare and potentially fatal cancer currently...
SHANGHAI, China — Alebund Pharmaceuticals (“Alebund” or the “Company”), an integrated biopharmaceutical company focusing on developing innovative therapies for renal diseases and related chronic conditions, announced the database lock was achieved on June 16, 2025 for the pivotal phase 3 study of its investigational drug AP301, a new generation of...
TOKYO, Japan — Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that the final data from the global Phase III ALEX study (NCT02075840) and the latest results from the global Phase III ALINA study (NCT03456076) of its anti-cancer agent/ALK inhibitor Alecensa (generic name: alectinib) for anaplastic lymphoma kinase (ALK)-positive non-small cell lung...
NATICK, Mass. & LONDON, UK — Aleta Biotherapeutics, a clinical stage, immuno-oncology company with a CAR T-Cell Engager (CTE) platform that enables cell cancer therapies to work more effectively, and Cancer Research UK’s Centre for Drug Development, today announce the first patient was dosed in a Phase 1/2 clinical trial....
Alexion, AstraZeneca Rare Disease, will showcase the potential for its pioneering therapies to redefine the treatment landscape for certain rare neurological diseases at the American Academy of Neurology (AAN) Annual Meeting, April 22-27, 2023. The company will present 19 abstracts, including eight oral presentations, across generalized myasthenia gravis (gMG), neuromyelitis optica spectrum disorder (NMOSD), Wilson disease and dermatomyositis.
BOSTON – Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of ULTOMIRIS® (ravulizumab-cwvz) to include children (one month of age and older) and adolescents with paroxysmal nocturnal hemoglobinuria (PNH). ULTOMIRIS, a long-acting C5 inhibitor that offers immediate, complete and sustained...
BOSTON – Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced positive topline results from a Phase 3 study evaluating the safety and efficacy of ULTOMIRIS® (ravulizumab-cwvz) in adults with generalized myasthenia gravis (gMG). The study met, with high statistical significance, its primary endpoint of change from baseline in the Myasthenia Gravis-Activities of Daily Living...