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...
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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 / 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...
INDIANAPOLIS – Researchers from Indiana University-Purdue University Indianapolis (IUPUI) have developed Distributed Drug Discovery (D3), a new low-cost strategy to accelerate the discovery of drugs to treat neglected diseases such as tuberculosis, leprosy, leshmaniasis, dengue fever, and Chagas disease. Even in times of economic prosperity, the pharmaceutical industry has often...
HONG KONG — Akeso, Inc. (9926.HK) is excited to announce that its globally first-in-class PD-1/VEGF bispecific antibody, ivonescimab, has received approval from the National Medical Products Administration (NMPA) for its supplementary New Drug Application (sNDA) for use as a monotherapy for the first-line treatment of PD-L1-positive (TPS ≥ 1%) non-small...
Paris, France – Ivosidenib is under clinical development by Les Laboratoires Servier and currently in Phase II for Chondrosarcoma. According to GlobalData, Phase II drugs for Chondrosarcoma does not have sufficient historical data to build an indication benchmark PTSR for Phase II. Ivosidenib overview Ivosidenib (Tibsovo / AG-120) acts as...
Redmond, WA and Princeton, NJ – SystImmune Inc. (SystImmune), a clinical-stage biotechnology company, and Bristol Myers Squibb today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to izalontamab brengitecan (iza-bren) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC)...
New compelling results demonstrate 18 months of both sustained reduction in immunoglobulin G antibodies and sustained improvement in gMG symptoms in pivotal Vivacity-MG3 study and open-label extension phase Up to 128 weeks and 180 patient years of follow-up in the open-label extensiona confirm a safety profile consistent with the Phase 3...
First and only FcRn blocker approved in anti-AChR and anti-MuSK antibody positive adults and pediatric gMG patients aged 12 and older IMAAVY delivered rapid and substantial reduction in immunoglobulin G (IgG) levels, one of the root causes of gMG, in both the adult and pediatric pivotal studies gMG...
Somerset, NJ – Legend Biotech announced in an SEC filing on Tuesday that the FDA will convene its Oncologic Drugs Advisory Committee to discuss the use of its Johnson & Johnson-partnered Carvykti (ciltacabtagene autoleucel) in earlier lines of treatment for multiple myeloma. The panel of external experts will evaluate J&J...