Sarepta and Roche face a regulatory setback as the EMA's CHMP issues a negative opinion on Elevidys for Duchenne muscular ...

Mike Pence's think tank is asking the Food and Drug Administration to turn over documents related to the dangers of the ...

At a recent FDA panel on SSRIs in pregnancy, the chair suggested rising antidepressant use may be contributing to — not ...

Preliminary data from clinical trials of tecovirimat as a treatment for mpox virus infection have given disappointing results ...

The European Medicines Agency has recommended the approval of lenacapavir, a new bi-annual injectable drug aimed at ...

The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and ...

Jyong Biotech targets urinary disorders with a novel botanical pipeline, but clinical and liquidity risks temper near-term ...

CHENNAI: Gilead Sciences has achieved another milestone in its efforts to bring in a preventive drug to curb the still ...

On April 22, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) announced a plan to phase ...

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

Despite a new setback for Elevidys in Europe, Roche—which markets Sarepta’s gene therapy outside the U.S.—remains committed ...