简介:
The FDA continued on a tear in the fourth quarter, approving some 20 new products and 4 biosimilars. Among the green lights are the first drug approval for any tumor with a specific gene fusion and the first new flu drug in 20 years. Two decisions on gene therapies, one in the United States and one in the European Union, are coming up. The first clinical trial for a phage cocktail in a topical burn application failed; it reduced bacterial loads, but less than the standard-of-care antibiotic.