Shares of Agios Pharmaceuticals jumped nearly 16% on Wednesday after the U.S. Food and Drug Administration approved the expanded use of its drug for the treatment of a type of blood disorder. The drug,

The FDA approved Nufymco as an interchangeable biosimilar to Lucentis, making it the second approved ranibizumab biosimilar in the U.S. from Formycon and Bioeq, the companies announced in a press release.

Billions of prescriptions for generic drugs are filled in the U.S. annually. The FDA tests only a few dozen of them every year, its own records show, and it has largely dismissed warnings about contaminants,

The U.S. Food and Drug Administration has approved Omeros' drug for a dangerous transplant complication, marking the first treatment to be greenlit for the condition, the company said on Wednesday.

A memo from Dr. Vinay Prasad​, the head of the FDA's Center for Biologics Evaluation and Research, may signal an effort to to rewrite the rules governing the U.S. vaccine system.

Sanofi agreed to buy Dynavax Technologies Corp. for about $2.2 billion, as it seeks to expand a vaccines business currently anchored by its flu shot franchise.

The Food and Drug Administration has issued several recalls for cookies, chocolates and holiday barks ahead of Christmas.

Agios Pharmaceuticals AGIO announced that the FDA has approved Aqvesme (mitapivat) for the treatment of adult patients with alpha- or beta-thalassemia. With this approval, Aqvesme becomes the only FDA-approved drug for the treatment of non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia.