CDER’s Accelerating Rare disease Cures (ARC) Program harnesses CDER’s collective expertise and activities to provide strategic overview and coordination of CDER’s rare disease activities. CDER’s ARC Program is governed by leadership from across CDER’s Office of the Center Director, Office of New Drugs, and the Office of Translational Sciences. The program...
treatment News
Intas and its subsidiary Accord Healthcare lead commercialisation in Europe and India. In December 2022, serplulimab received orphan drug designation from the EC for the treatment of SCLC, this was recently reviewed by the committee and renewed. ESMO has scored serplulimab 4 out of 5 on their magnitude of clinical benefit scale (MCBS) in...
St. Louis, MO – A drug used to treat children with epilepsy prevents brain tumor formation and growth in two mouse models of neurofibromatosis type 1 (NF1), according to a study by researchers at Washington University School of Medicine in St. Louis. NF1 is a genetic condition that causes tumors...
Heidelberg, Germany – A common over-the-counter ingredient in many cough syrups may have a greater purpose for people suffering from lung fibrosis that is related to any number of serious health conditions. Scientists from EMBL Heidelberg were part of a collaborative effort to discover an effective treatment for lung fibrosis...
London, UK – A single test to speed up diagnosis of a serious disease in pregnant women does not need to be repeated, new research has found. Results from the PARROT-2 trial, published today in the Lancet by researchers from King’s College London and funded by Jon Moulton Charitable Trust,...
Chicago, Illinois – A new antibiotic that works by disrupting two different cellular targets would make it 100 million times more difficult for bacteria to evolve resistance, according to new research from the University of Illinois Chicago. For a new paper in Nature Chemical Biology, researchers probed how a class of synthetic...
Ann Arbor, Michigan – A team of researchers at the University of Michigan Health Rogel Cancer Center has designed a molecule that impairs signaling mediated by two key drivers of cancer therapy resistance. The design and preclinical evaluation of the inhibitor, MTX-531 was published in Nature Cancer. Researchers, led by...
IRVING, Texas -Acentrus Specialty™, a national network of health systems and hospitals committed to providing specialty pharmacy care for their patients, has finalized an agreement with Chiasma, Inc. (NASDAQ: CHMA) to provide qualified Acentrus clients access to MYCAPSSA® (octreotide), delayed-release oral capsules for long-term maintenance treatment in acromegaly patients who...
ALAMEDA, Calif. and TAIPEI — Acepodia (6976:TT), a clinical stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) and allogeneic gamma delta 2 (γδ2) T cell platforms to address gaps in cancer care, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s...
LONDON, UK — Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing AI-powered precision T cell therapies targeting clonal neoantigens to treat solid tumors, today announced interim Phase I/IIa data on the use of clonal neoantigen reactive T cells (cNeT) from the CHIRON study in advanced unresectable or metastatic...