The U.S. FDA has approved Novo Nordisk's Ozempic for reducing the risk of kidney failure and disease progression, as well as ...

Ozempic, or semaglutide, can now be used to reduce the risk of worsening kidney disease or kidney failure in adults with type ...

The European Medicines Agency (EMA) said on Monday it would no longer post on X and would use rival Bluesky instead, becoming ...

Reported a robust objective response rate of 75.5% from the Phase 1 study of NX-5948 in patients with relapsed/refractory CLL/SLL at the 66th ...

ImmunityBio (IBRX) announced the European Medicines Agency has accepted for review and begun assessing the marketing authorization application ...

The European Medicines Agency (EMA), which is the regulator for vaccines and medicine in the European Union (EU), has stopped ...

GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency (EMA) has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix (GSK’s Recombinant ...

The European Medicines Agency (EMA) has decided to stop using the social media platform X due to content concerns and will instead use Bluesky. This move aligns with other organizations stepping back ...

Biogen and Eisai have won Food and Drug Administration approval of an intravenous maintenance dosing of their Leqembi drug for early Alzheimer's disease. The companies late Sunday said the FDA ...

Biogen said the U.S. Food and Drug Administration has accepted its supplemental new-drug application, while the European Medicines Agency has validated its application, which confirms that the ...

This European review of the prefilled syringe follows GSK's receipt of approval from the US Food & Drug Administration on January 8. GSK is also investigating submission of the new presentation to ...