The drugs’ active ingredient, glatiramer acetate, has been linked to more than 80 cases of anaphylaxis worldwide since ...

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

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

At oral arguments earlier this week the Supreme Court was skeptical of the Food and Drug Administration’s effort to block a North Carolina-based company from challenging the denial of its application ...

Teva Pharmaceutical’s Copaxone was approved by the FDA in 1996 to treat relapsing forms of MS, an autoimmune disorder that ...

The FDA issued a boxed warning for anaphylaxis risk linked to Glatiramer acetate and Glatopa, used in MS treatment.

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 has added a boxed warning, its most serious designation, to Copaxone and Glatopa due to the risk of anaphylaxis, a rare but serious allergic reaction. This severe reaction can occur at any ...

Overall, women with MS have a 26% increased risk of mental illness during pregnancy and a 33% increased risk after giving birth, compared to women without the degenerative nerve disease.

After years of legal wrangling surrounding Teva’s Copaxone, the latest hit to the lucrative multiple sclerosis drug comes in ...

The U.S. Supreme Court appeared skeptical Tuesday of the government's attempt to limit the number of Food and Drug ...