emd serono

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

by Nile
March 11, 2021

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious… Read More »Insights+: Breakthrough Therapy Designation by the US FDA in 2020

EMD Serono targeted therapy gets speedy FDA approval for lung cancer

by Nile
February 4, 2021

EMD Serono’s Tepmetko is one of a number of targeted cancer therapies that have passed FDA muster in the past year. The decision sets up the German company’s pill for head-to-head competition with a Novartis drug targeting the same genetic signature.