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 […]readmore
Tags : EMD Serono
Shots: The companies have completed the submission of sBLA to the US FDA as 1L maintenance therapy for patients with LA/m-UC and have received FDA’s BT designation for the same […]readmore
Shots: The P-III JAVELIN Head and Neck 100 study involve assessing of Bavencio (avelumab) + CRT followed by avelumab maintenance vs CRT alone in 697 patients with previously untreated LA […]readmore
Shots: The approval is based on P-III CLARITY study assessing Mavenclad vs PBO in 1,976 patients with RRMS and SPMS in adults P-III CLARITY study results: 58% reduction in the […]readmore