EXTON, Pa. — ViroPharma Incorporated (Nasdaq: VPHM) today announced that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) related to its supplemental Biologics License Application (sBLA) for Cinryze(TM) (C1 esterase inhibitor [human]) as a treatment for acute attacks of hereditary angioedema (HAE). The...
treatment News
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...
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...
SAN MATEO, Calif. — Vivace Therapeutics, Inc., a small molecule discovery and development company developing first-in-class cancer therapies targeting the Hippo pathway, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to VT3989 for the treatment of mesothelioma in the United States. VT3989, the company’s first-in-class...
SAN MATEO, Calif. — Vivace Therapeutics, Inc., a small molecule discovery and development company developing first-in-class cancer therapies targeting the Hippo pathway, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to VT3989, the company’s first-in-class and best-in-class transcriptional enhanced associate domain (TEAD) autopalmitoylation inhibitor....
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...
BOSTON, Mass. — Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that its collaborator, RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), reported positive 48-week results from its Phase 3 study conducted in China evaluating telitacicept in primary Sjögren’s disease. The study met...
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...