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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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New Drug Designations - November 2023
INSIGHTS+

New Drug Designations – November 2023

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EMA and China. This month’s report includes 3 biological drugs, 12 small molecules, 13 cell and gene therapies, 1 peptide, 3 exosome-based therapy and 4 devices Atsena Therapeutics’ capsid AAV.SPR gene therapy, focused on the treatment of Leber congenital…
December 27, 2023

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New Drug Designations - October 2023
INSIGHTS+

New Drug Designations – October 2023

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA and the EMA. This month’s report includes 2 biological drugs, 12 small molecules, 10 cell and gene therapies, 2 vaccines, 1 peptide, 1 exosome-based therapy and 3 devices HuidaGene Therapeutics’ HG204 CRISPR RNA-editing therapy, focused on the treatment of MECP2 duplication…
November 20, 2023

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