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

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 ...

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

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

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

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 drug menace in Jammu and Kashmir has reached an alarming tipping point. What was once a creeping concern has now exploded ...

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

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 ...