HGSI/GSK's Benlysta Gets BLySfully Clean Labeling, Escaping Feared Restrictions
The indication is notable for what it does not contain, which is language specifically excluding African Americans or patients with severe active lupus nephritis or severe central nervous system lupus.
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A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.
US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.
Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.