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 ...
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.
The FDA added a boxed warning about rare cases of anaphylaxis associated with the multiple sclerosis (MS) drug glatiramer ...
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 ...
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.
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 ...
The U.S. Food and Drug Administration has issued a recall on a popular skin moisturizer that's available nationwide. Do you have this product?
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 ...