In December, the FDA finalized a rule that updates the nutritional ... Foods that meet the new requirements can start using the label once the rule is effective, while those that don’t meet ...

Alnylam Pharmaceuticals ALNY announced that the FDA had approved its regulatory filing seeking the label expansion of its ...

This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with ...

The FDA approved an expanded label for Iluvien, which is now indicated for the treatment of chronic noninfectious uveitis ...

Zepbound contains the same active ingredient, tirzepatide, as Mounjaro, which is also made by Lilly and is FDA-approved to ...

Heart disease patients now have another treatment option. The U.S. Food and Drug Administration has approved Alnylam ...

Products must note that they can increase blood pressure, but boxed warnings about adverse cardiovascular events can be ...

An off-label prescription drug has been shown to help children with autism gain the ability to speak. Leucovorin is used for cancer patients, but doctors are pushing for its approval for autism.

There was an incorrect back label placed on the product for undeclared ... allergic reactions if they consume these products. The FDA updated the risk level of this recall to Class I, which ...

The label expansion couls help J&J establish Tremfya as a successor to Stelara, which is now facing a growing biosimilar ...

(RTTNews) - ANI Pharmaceuticals, Inc. (ANIP) announced Friday that the U.S. Food and Drug Administration (FDA) has approved an expanded label for ILUVIEN (fluocinolone acetonide intravitreal ...

The FDA on Thursday approved Fabhalta (iptacopan) to treat complement 3 glomerulopathy (CG3), a progressive, ultrarare kidney ...