Sarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the FDA.

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.

Welcome to this week’s Food Exec Brief, a roundup of the most important news shaping food and beverage manufacturing, from ...

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

The FDA is still on track to meet its user fee targets despite a higher-than-normal vacancy rate among scientific reviewers.

U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS), and Centers for Disease Control and Prevention ...

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

Always unexpected and rarely ever any fun, product recalls have a way of catching us all by surprise. And as much as we’d ...

Missouri Attorney General Andrew Bailey is suing the national Planned Parenthood organization over its claims regarding the ...