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.

First of many planned label expansions supporting Vision 2030 goal to become the leading endocrinology rare disease companyOn track to initiate basket trial for ISS, SHOX deficiency, Turner syndrome, ...

Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping ...

Avant Technologies Inc. (OTCQB: AVAI) ("Avant" or the "Company"), an emerging technology company developing healthcare solutions, and its Joint Venture partner, Ainnova Tech, Inc. (Ainnova), a leading ...

Apellis Pharma (APLS) stock in focus as the FDA expands the label for its injectable therapy Empaveli to treat rare kidney ...

Improving how the FDA disseminates already-public information about approved drugs may be unsexy, but it would be a big step ...

Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug ...

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

A dozen lawsuits have been filed over spinal cord stimulators, which are medical devices surgically implanted to reduce chronic back pain. The suits name device manufacturers, such as Abbott and ...

Trump administration regulators have approved Skydance Media’s $8 billion bid to acquire Paramount, the parent company of CBS ...

Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines 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.