BOSTON & SHANGHAI, September 2, 2024 – Skyline Therapeutics, a gene therapy company focused on innovative treatments for rare and severe diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for SKG1108....
Following the FDA’s May release of long-awaited draft guidance explaining how companies can win designations for certain cell and gene therapy “platform” technologies, companies like Regeneron, Alnylam, Verve Therapeutics and others are seeking more clarity from the...
SILVER SPRING, Md., Aug. 22, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that...
RNA Therapeutics, a clinical-stage biotechnology company focused on innovative applications of mRNA-based delivery systems for therapeutic proteins and vaccines, announced that it has received a written response to its Pre-Investigational New Drug Application...
Agency Continues to Support Development of Overdose Reversal Drugs including Naloxone and Nalmefene SILVER SPRING, Md., Aug. 7, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Zurnai, the first nalmefene hydrochloride auto-injector for...
