The US FDA has appointed George Francis Tidmarsh, MD, PhD, as director of the Center for Drug Evaluation and Research.

The Revell family hoped a gene therapy could buy time for their sons, who have a rare and fatal disease. After two patients died, the drug’s manufacturer halted dosing under pressure from the FDA.

The FDA may remove the warning labels on hormone replacement therapies used to treat the symptoms of menopause. Doctors say ...

Institutional investors including Armistice Capital, RTW Investments, and Wellington Management have increased their exposure ...

The FDA may remove the warning labels on hormone replacement therapies used to treat the symptoms of menopause. Doctors say ...

The U.S. Food and Drug Administration has extended its review of Bayer's experimental menopause relief drug, the German company said on Friday.

LONDON (AP) — The European Medicines Agency has recommended authorizing a twice-yearly injectable drug aimed at preventing ...

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

From softwares to implants, here are 10 spine products earning FDA nods since May 15. 1. Accelus’ FlareHawk interbody fusion device was FDA-cleared for use in MRI scanning under certain conditions.

A joint investigation by KFF Health News and NBC News found that cosmetic surgery chains have been the target of scores of ...

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

LONDON – The European Medicines Agency has recommended authorizing a twice-yearly injectable drug aimed at preventing HIV, ...