Hormone therapy has endured a rather bumpy history after the Women’s Health Initiative published clinical trial data in 2002 ...

A panel of 12 experts in the menopause field reexamined the findings of the 2002 Women’s Health Initiative study that said ...

Members of an FDA expert panel discussed reassessing boxed warnings for menopausal HT and how to better educate patients and ...

A meeting held by the FDA Thursday spotlighted debate over black box warnings that have limited use of hormone treatment for ...

Experts worry the warning on vaginal estrogen menopause treatments is doing more harm than good and is not supported by science.

JUUL GETS ITS CROWN — The FDA authorized Juul’s applications on Thursday to sell e-cigarettes in the U.S., determining ...

A decades-old label has scared women (and their doctors) away from safe and effective menopause treatment. That could finally change today.

The U.S. Food & Drug Administration has extended its review of Ascendis Pharma's therapy to treat adult patients with a hormone disorder by three months, the company said on Tuesday.

The FDA approved TherapeuticsMD’s hormone therapy Imvexxy for a vaginal condition linked to low estrogen levels during menopause, the company announced May 30. 1. Imvexxy is intended to treat ...

Shares of Ascendis Pharma ASND lost more than 5% on Tuesday after management announced that the FDA extended the review period for its regulatory filing for a hormone replacement therapy by an ...

FDA grants Breakthrough Therapy Designation to Roche’s inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation ...

U.S.-listed shares of the company were down 6.6% in late afternoon trading. The health regulator notified that data submitted for the ongoing review of the therapy, called TransCon PTH ...