The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and the U.K. have already cleared it for use.

Cat’s-claw, chaparral, and blue-green algae (spirulina) supplements for rheumatoid arthritis may do more harm than good.

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 ...

Eli Lilly's Alzheimer's drug, donanemab (Kisqali), just got a thumbs-up from the European Medicines Agency's (EMA) expert ...

European regulators on Friday said that the Duchenne muscular dystrophy gene therapy Elevidys should not be approved ...

There was a lot of excitement when Tepezza became the first drug approved for the treatment of thyroid eye disease in January ...

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

Xuewu Liu, a Chinese inventor who has no medical training or credentials of any kind, is charging cancer patients $20,000 for ...