Lilly is investing $3 billion to expand its recently acquired manufacturing facility in Wisconsin, while Amgen is investing $1 billion to expand its facility in North Carolina.

With this approval, HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] becomes the first and only facilitated subcutaneous immunoglobulin available in Japan to treat ...

Pharmaceutical training programs are enhanced by integrating ICH quality risk management considerations.

FDA's approval of Hikma Pharmaceuticals’ liraglutide injection makes this product the first generic version of Victoza, a GLP-1 receptor agonist.

In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA ...