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INSIGHTS+

EMA Marketing Authorization of New Drugs in October 2025  

Shots:  Innovation in drug development continues to redefine the future of healthcare, fueling bold scientific partnerships and transforming how diseases are understood, managed, and treated across every therapeutic frontier  In October, the EMA issued positive CHMP opinions for two significant therapies: Sanofi’s Wayrilz (rilzabrutinib) for adults with immune thrombocytopenia, and Insmed’s Brinsupri (brensocatib) for the…
November 18, 2025

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VIEWPOINTS_Michael Moran1_Julie Blaedel2_2024
VIEWPOINTS

Julie Blaedel from Genmab and Michael Moran from AbbVie Discuss the Conditional EC Approval of TEPKINLY in a Stimulating Conversation with PharmaShots

Shots:    Diffuse large B-cell lymphoma remains the most common type of non-Hodgkin lymphoma. With limited therapeutic options for patients whose disease gets relapsed or refractory, AbbVie and Genmab’s TEPKINLY is one-of-a-kind monotherapy for adult patients with relapsed or refractory DLBCL   Post EC’s conditional approval, Julie Blaedel & Michael Moran engage in an enlightening conversation with…
January 10, 2024

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New Drug Designations - August 2023
INSIGHTS+

New Drug Designations – August 2023

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, Japan, and China. This month’s report includes 8 biological drugs, 13 small molecules, 4 cell and gene therapies, 3 diagnostic tests and 5 devices  Genprex’ Reqorsa, focused on the treatment of SCLC, is the drug to receive ODD…
September 18, 2023

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