By Joshua KirbyNovartis AG said Wednesday that its drug Vijoice (alpelisib) has been granted accelerated approval in the U.S. for the treatment of adults and children with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. The U.S. Food & Drug Administration gave the approval to Vijoice for adults and children above two years of age suffering from the PROS, a spectrum of rare conditions characterized by atypical overgrowths and anomalies in blood vessels, the lymphatic system and other tissues, the Swiss drugmaker said.
Source: Wall Street Journal April 06, 2022 15:22 UTC