MILAN, Italy – Italfarmaco S.p.A. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to givinostat for the treatment of patients with polycythemia vera (PV), a rare haematologic cancer, for which treatment options are limited. “The FDA decision to grant givinostat Fast Track designation underscores the...
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MILAN, Italy – Italfarmaco S.p.A. announced today that additional data on givinostat for the treatment of Duchenne muscular dystrophy (DMD) are being presented at the 30th annual International Congress of the World Muscle Society (WMS) held October 7-11 in Vienna, Austria. Poster presentations highlight the long-term safety of givinostat in patients with DMD,...
MILAN, Italy — Italfarmaco S.p.A. announced today that the U.S. Food and Drug Administration (FDA) has approved Duvyzat™ (givinostat), a novel histone deacetylase (HDAC) inhibitor, for the treatment of patients 6 years or older with Duchenne muscular dystrophy (DMD), a rare X-linked progressive and life-limiting neuromuscular condition with symptoms from...
ORLANDO, Florida — Until Susan Caldwell of Waxahachie, Texas, learned in 2016 that her 8-year-old son Ryan Michael had Duchenne muscular dystrophy (DMD), she had never heard of the disease—and only vaguely knew of muscular dystrophy, thanks to the Jerry Lewis Telethon. “It was devastating,” she recalled. “I had met...
Isernia, Italy – A study conducted by the Research Unit of Epidemiology and Prevention at the I.R.C.C.S. Neuromed in Pozzilli, in collaboration with the LUM University of Casamassima, shows that high consumption of ultra-processed foods is associated with the acceleration of biological aging, regardless of the nutritional quality of the...
HOUSTON – Iterion Therapeutics, Inc., a venture-backed, clinical stage biotechnology company developing novel cancer therapeutics, announced today that it has confirmed the safety of Tegavivint, a novel, potent and selective nuclear beta-catenin inhibitor, after completing enrollment and dosing the final patient in a multicenter Phase 1/2a dose expansion clinical study...
CONCORD, Mass. — ITF Therapeutics LLC, the U.S. affiliate of Italfarmaco, today announced publication of positive long-term safety and efficacy data for givinostat as a treatment for Duchenne muscular dystrophy (DMD) from the company’s open-label extensions of its Phase 2 and Phase 3 (EPIDYS) trials. The results, published in Annals of Clinical and...
CONCORD, Mass. — ITF Therapeutics LLC, the U.S. affiliate of Italfarmaco, today announced the presentation of seven abstracts at the Muscular Dystrophy Association (MDA) Clinical and Scientific Conference being held March 16-19, 2025, in Dallas, Texas. The poster presentations include data from the Phase 3 EPIDYS study and the company’s...
GARCHING, Germany – ITM AG announced today the successful close of a convertible loan financing totaling EUR 90 million (USD 109 million) led by Petrichor Healthcare Capital Management with participation of additional undisclosed investors. The proceeds will support the expansion of ITM’s precision oncology pipeline as well as fund late-stage development and market access...
Garching / Munich, Germany – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ITM-94 ([68Ga]Ga-DPI-4452) as a diagnostic agent for the detection of clear cell renal cell carcinoma (ccRCC). The Fast Track designation...