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INSIGHTS+

New Drug Designations – May 2025  

Shots:      PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada and NMPA    The May 2025 report covers designations granted to 44 drugs and 5 medical devices, spanning 15 small molecules, 7 biologics, 13 cell and gene therapies & 5 medical devices among others   …
June 24, 2025

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INSIGHTS+

New Drug Designations – April 2025  

Shots:     PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada and NMPA   The April 2025 report covers designations granted to 36 drugs and 6 medical devices, spanning 14 small molecules, 3 biologics, 11 cell and gene therapies & 6 medical devices among…
May 27, 2025

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New Drug Designations - October 2024
INSIGHTS+

New Drug Designations – October 2024

Shots:   PharmaShots' designation report provides a concise overview of the latest drug designations by major regulatory authorities, including the FDA, NMPA, and EMA   The October 2024 report covers designations granted to 33 drugs and 2 devices, encompassing 14 small molecules, 4 biologics, 8 cell and gene therapies, and 2 medical devices.  Significant trends this month…
November 26, 2024

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New Drug Designations - September 2024
INSIGHTS+

New Drug Designations – September 2024

Shots:   PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA, Health Canada and EMA.  The September 2024 report covers regulatory designations for 42 drugs and 1 device, including 16 small molecules, 6 biologics, 12 cell and gene therapies, and 1 device, among others.  Significant trends this month…
October 29, 2024

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New Drug Designations - April 2024
INSIGHTS+

New Drug Designations – April 2024

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 11 small molecules, 7 biologics, 7 cell & gene therapies, 1 antiviral, 1 peptide and 3 devices   Lisata Therapeutics’ LSTA1 received ODD this month and was granted with…
May 30, 2024

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New Drug Designations - March 2024
INSIGHTS+

New Drug Designations – March 2024

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, MHRA and EC. This month’s report includes designations allotted to 10 small molecules, 6 biologics, 5 cell & gene therapy, 1 recombinant fusion protein, 2 actineoplastics, 1 antidepressant, 1 drug conjugate, 1 analgesic and 6 devices    Trellis Bioscience's…
April 30, 2024

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Viewpoints_Alex Zimmerman_Alexander Lin
VIEWPOINTS

Alex Zimmerman and Alexander Lin Share Insights on the FDA Breakthrough Device Designation Received for Non-Invasive Virtual Biopsy Technology

Shots: Alex Zimmerman talked about virtual biopsy technology using standard MRI scanners. The technology will allow doctors to understand brain imaging via chemical indicators more extensively Alexander Lin spoke about the data on which the BDD was granted by the FDA and the usage of Magnetic Resonance Spectroscopy (MRS) by this software BrainSpec is a…
October 10, 2022

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Viewpoints_Erika Ross
VIEWPOINTS

Erika Ross, Director of Clinical & Applied Research at Abbott Shares Insights on FDA Breakthrough Device Designation to Explore its DBS System to Treat Treatment-Resistant Depression

Shots:  Erika spoke about the FDA Breakthrough Device Designation received by Abbott to investigate its deep brain stimulation (DBS) system to treat treatment-resistant depression (TRD) Erika also talked about how NeuroSphere Virtual Clinic is compatible with the  deep brain stimulation (DBS) system  The interview gives an understanding of Abbott’s vision to bring life-changing technologies in…
October 5, 2022

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