This period of statutory exclusivity means that the FDA will not approve another mesenchymal stromal or stem cell (MSC) products for this indication during the 7-year period from the approval of ...

US FDA Expands Use of Merck's Cancer Drug for Adrenal ... caused by certain genetic syndromes or mutations. The regulator's approval was based on a study in which Welireg showed an objective ...

The FDA announced it has approved the use of two color additives from natural sources in over a dozen foods and beverages while expanding the approval of another. According to a press release ...

This approval marks a historic moment for the EB community as the third FDA approved treatment and the first autologous, cell-based gene therapy for RDEB (Recessive Dystrophic Epidermolysis Bullosa).

The U.S. Food and Drug Administration (FDA) approved on Friday additional ... The agency approved two dyes and expanded approval of a third, meaning it can now be used in a wider range of food ...