TOKYO, Japan — Astellas Pharma Inc. today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted priority review for the company’s Supplemental New Drug Application (sNDA) for PADCEV™ (enfortumab vedotin (genetical recombination)) with KEYTRUDA® (pembrolizumab (genetical recombination)) as a combination therapy for the first-line treatment of adult...
treatment News
CLEVELAND, Ohio — A recent study from researchers at University Hospitals (UH) Connor Whole Health and UH Rainbow Babies & Children’s Hospital describes a quality improvement project where pain screening procedures were embedded within an outpatient pediatric sickle cell disease (SCD) clinic. The study examined (1) the feasibility of routine pain...
ROCKLAND, Mass. — EMD Serono, the Healthcare business of Merck KGaA in the U.S. and Canada, today announced new real-world data that continue to reinforce the JAVELIN Bladder regimen of first-line platinum-based chemotherapy followed by BAVENCIO® (avelumab) maintenance as a standard of care for eligible patients with locally advanced or...
Aurora, Colorado – New research overseen by University of Colorado Cancer Center member Rebecca Schweppe, PhD, could lead to improved treatment for people with thyroid cancer characterized by a mutation in the BRAF gene, a mutation also responsible for some types of melanoma, colorectal cancer, leukemia, lymphoma, and ovarian cancer....
Melbourne, Australia – In the study led by the Peter Doherty Institute for Infection and Immunity (Doherty Institute) and published in Science Immunology, the researchers found that CD4+ T cells, traditionally called ‘helper T cells’ for their role in aiding the activation of other immune cells, are remarkably effective in...
Leawood, Kansas – Researchers performed a meta-analysis of randomized trial studies that compared the use of amyloid-reducing monoclonal antibodies (MABs) in patients with Alzheimer dementia at a dose consistent with that used in Phase 3 or FDA approval trials with the use of a placebo. Their purpose was to evaluate...
SHANGHAI, China — Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its Birelentinib (DZD8586) for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia or small...
PRINCETON, N.J. – Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer. This approval...
LONDON, UK – GSK plc (LSE/NYSE: GSK) today announced that its B7-H3-targeted antibody-drug conjugate GSK’227, now referred to by its International Nonproprietary Name, risvutatug rezetecan, has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of small-cell lung cancer (SCLC). The ODD was...
A disease registry may serve as a more suitable data source for evaluation of factor VIII inhibitors in pediatric patients receiving orphan drug treatment for hemophilia A compared with a single-arm clinical trial. While several new factor VIII products have been developed in recent years, the rarity of hemophilia A...