SHANGHAI, China — VISEN Pharmaceuticals (VISEN), an innovative biopharmaceutical company focused on endocrine diseases, today announced that the Biologics License Application (BLA) for Lonapegsomatropin (TransCon hGH) was accepted by the China National Medical Products Administration (NMPA). Lonapegsomatropin is the first once-weekly administrated growth hormone approved by both the U.S. Food...
treatment News
SOUTH SAN FRANCISCO, Calif. — Vistagen, a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders, today announced that the European Patent Office (EPO) issued a Notice of Intention to Grant a patent related to the...
Urbana-Champaign, Illinois – The Speech Accessibility Project is now recruiting U.S. and Puerto Rican adults with cerebral palsy. Those interested can sign up online. Funded by Big Tech companies Amazon, Apple, Google, Meta, and Microsoft, the University of Illinois Urbana-Champaign aims to train voice recognition technologies to understand people with diverse...
CAMBRIDGE, Mass. – Voyager Therapeutics, Inc. (Nasdaq: VYGR), a clinical-stage gene therapy company developing life-changing treatments for severe neurological diseases, today announced the U.S. Food and Drug Administration (FDA) has removed its clinical hold on the company’s Investigational New Drug (IND) application for VY-HTT01, a gene therapy candidate for the...
LEXINGTON, Mass. — Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to advancing neurogenetic medicines, today announced new data from its two preclinical programs targeting pathological tau for the treatment of Alzheimer’s disease. Data on VY-TAU01, Voyager’s lead anti-tau antibody candidate, and on Voyager’s tau silencing gene therapy program...
Cambridge, England – Voydeya (danicopan) has been approved in the US as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular haemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH). Voydeya is a first-in-class, oral, Factor D inhibitor developed as an add-on to standard-of-care Ultomiris (ravulizumab) or Soliris...
WILMINGTON, Del. — AstraZeneca Pharmaceuticals LP and Ionis’ WAINUA™ (eplontersen) has been approved in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults, commonly referred to as hATTR-PN or ATTRv-PN. WAINUA is the only approved medicine for the treatment of ATTRv-PN that can be self-administered...
WASHINGTON DC – Gene-editing technologies are progressing fast, and there are now more than 100 ongoing trials for new therapies and diagnostics based on CRISPR-Cas, zinc finger nucleases, TALENS, and base editors. While most of these trials are evaluating ex vivo gene-edited cell-based therapies for cancers and genetic blood disorders,...
Guildford, England. Insulin icodec, a once-weekly basal injection to treat type 1 diabetes, has the potential to be as effective in managing the condition as daily basal insulin treatments, according to research from the University of Surrey. The results of the year-long phase 3 clinical trial could revolutionise the future...
New York, NY – Patients who have drug-resistant tuberculosis (TB) have a similar microbiological response to bedaquiline-based second-line medications as patients with drug-sensitive TB taking first-line regimens, according to researchers at Weill Cornell Medicine in New York and GHESKIO Centers in Haiti. Second-line medications are those that are given when...