LAS VEGAS, NV, Feb. 24, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – BioAdaptives, Inc. (OTCMkts: BDPT) announced today positive results from a study conducted by Stanford Medical School Professor,...
Guerbet LLC takes note of the drug safety communication1 issued on December 19, 2017 by the U.S. Food and Drug Administration (FDA), regarding gadolinium-based contrast agents (GBCAs) and the retention of gadolinium in the body.
The Pharmacovigilance and Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorizations for four linear gadolinium contrast agents. PRAC put forward the proposal after finding “convincing evidence” accumulations of gadolinium are present in the brain many months after the contrast agent is last injected
Top-line data show that both the ozanimod 1 mg and 0.5 mg treatment arms demonstrated statistically significant and clinically meaningful improvements compared to Avonex® for the primary endpoint of ARR and the measured secondary endpoints of the number of gadolinium-enhancing MRI lesions and the number of new or enlarging T2 MRI lesions at month 12. As agreed to in the Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration, a pre-specified analysis on the time to onset of disability progression will be conducted using pooled results from both the SUNBEAM and RADIANCE phase III trials.