Regulatory officials have identified 82 cases worldwide from the FDA Adverse Event Reporting System of anaphylaxis associated ...

Today, the FDA issued a warning about the risk of anaphylaxis, a rare but life-threatening allergic reaction, linked to ...

The FDA added a boxed warning about rare cases of anaphylaxis associated with the multiple sclerosis (MS) drug glatiramer ...

Reports of anaphylaxis associated with the use of glatiramer acetate have prompted the Food and Drug Administration (FDA) to add a Boxed Warning to the prescribing information.

The Supreme Court will hear oral arguments on Tuesday in a clash over whether a North Carolina-based company can challenge the Food and Drug Administration’s denial of its application to market ...

The FDA said the biosimilar, called Tyruko, has been approved to treat adults with relapsing forms of MS and active secondary progressive MS, as well as for certain patients with Crohn's disease ...

The Government Accountability Office released findings this week that analyzed the FDA’s compliance with the Food Safety ...