Commissioner Marty Makary said in an interview with Politico’s Dasha Burns that the FDA will “look at the data” surrounding ...

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

Coffee company voluntarily recalls 154 Dark Pinon single-serve cups as a precaution after FDA found seal issues, though no ...

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

WASHINGTON D.C., DC — A Florida ice cream company has voluntarily recalled more than 110,000 ice cream bars and frozen ...

More than 100,000 ice cream bars recalled due to potential contamination. Products include fan favorites like chocolate ...

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

Over the past two years, at least 15 states have enacted laws requiring manufacturers of electronic nicotine delivery systems (ENDS) to certify ...

Bayer said the Food and Drug Administration extended the review period for its new drug application of elinzanetant, a treatment for moderate to severe vasomotor symptoms, also known as hot flashes, ...

Ritz peanut butter cracker sandwiches are being recalled due to the possible presence of undeclared peanuts, a major allergen ...

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

Keurig K-Cups are being recalled nationwide due to a packaging issue that could cause ink to run into the coffee during ...