Keyword: Breakthrough

News

Merck-Pfizer Avelumab gets FDA Breakthrough Therapy Status

19.11.2015 - A further regulatory milestone has been achieved by Merck KGaA and Pfizer after the US Food and Drug Administration (FDA) designated their potential skin cancer treatment avelumab...

News

Merck & Co Hepatitis C Drug to Lose "Breakthrough" Status

06.02.2015 - US regulators intend to rescind the "breakthrough therapy" designation for Merck & Co's hepatitis C combination treatment, a decision that could delay approval of the product by...