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

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

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

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 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.

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

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

Bayer announced an FDA review extension for Elinzanetant, its experimental menopausal hot flash therapy. Approval remains on track. REad more here.