NASH Drug Candidate Comes With ‘Serious Risks,’ Says FDA Staff
While citing obeticholic acid’s (Ocaliva) modest effect on a single surrogate endpoint for nonalcoholic steatohepatitis (NASH), FDA staff members raised “substantial concerns” over the frequency of drug-induced liver injury, along with a litany of other safety concerns. The assessment dims the prospect of regulatory approval as the oral drug makes an iffy second bid to […]
WHO Renames Monkeypox As Mpox, Citing Racism Concerns
LONDON (AP) — The World Health Organization has renamed monkeypox as mpox, citing concerns the original name of the decades-old animal disease could be construed as discriminatory and racist. The U.N. health agency said in a statement Monday that mpox was its new preferred name for monkeypox, saying that both monkeypox and mpox would be […]