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New Drug Designations: July 2025

New Drug Designations: July 2025

Shots:       PharmaShots’ Designation Report offers a concise overview of the latest drug and device designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA.    The July 2025 edition covers designations awarded to 47 drugs and 3 medical devices, comprising 23 small molecules, 9 biologics, 8 cell and gene therapies, and…

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VIEWPOINTS_Betty Woo_2023

In an Insightful Conversation with PharmaShots, Betty Woo Highlights Thermo Fisher’s Cell Therapy Collaboration Program

Shots:   Betty Woo, VP of Cell, Gene, and Advanced Therapies, Thermo Fisher Scientific discusses the evolution of ThermoFisher’s strategic collaboration with ArsenalBio    Betty highlights the development of programmable autologous T cells for the treatment of cancer and the cell therapy collaboration program   Betty believes that through innovation and partnership, they can tap into the full…

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New Drug Designations - June 2023

New Drug Designations – June 2023

Shots:  PharmaShots' designation report provides a condensed overview of several drugs and their designations by the US FDA, the EU, China, and the UK. This month’s report includes 7 biological drugs, 13 small molecules and 9 cell and gene therapies  CellCentric’s Inobrodib, for multiple myeloma and Rocket Pharmaceuticals’ RP-A601, for PKP2-arrhythmogenic cardiomyopathy were the two…

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