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

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...

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

Overview of Therapeutic Drug Monitoring MarketThe Global Therapeutic Drug Monitoring Market is valued at USD 2.5 Billion in ...

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

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

Overview of Companion Diagnostics MarketThe Companion Diagnostics Market is evolving rapidly, driven by the growing demand ...

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

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

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

A doctor has urged patients to proceed with caution when using cannabis during cancer immunotherapy and called for more ...