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New Drug Designations - September 2023

New Drug Designations - September 2023

October 16, 2023

FDA Launches a Pilot Program to Regulate the Safety Standards Associated with In vitro Diagnostic Tests to Identify Cancer Biomarkers

FDA Launches a Pilot Program to Regulate the Safety Standards Associated with In vitro Diagnostic Tests to Identify Cancer Biomark...

June 23, 2023

Alnylam’s Amvuttra (vutrisiran) Receives the US FDA’s Approval for Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis

Alnylam’s Amvuttra (vutrisiran) Receives the US FDA’s Approval for Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis

June 14, 2022

Glenmark’s Ryaltris Nasal Spray Receives the US FDA’s Approval for the Treatment of Seasonal Allergic Rhinitis

Glenmark’s Ryaltris Nasal Spray Receives the US FDA’s Approval for the Treatment of Seasonal Allergic Rhinitis

January 14, 2022

OncoOne Entered into an Agreement with GenScript ProBio for the Manufacturing of Monoclonal Antibody Therapies Targeting oxMIF

OncoOne Entered into an Agreement with GenScript ProBio for the Manufacturing of Monoclonal Antibody Therapies Targeting oxMIF

November 18, 2021

Oncorus Signs an Exclusive License Agreement with Gaeta for IL-12 in Combination with Immune Checkpoint Inhibitors to Treat Cancer

Oncorus Signs an Exclusive License Agreement with Gaeta for IL-12 in Combination with Immune Checkpoint Inhibitors to Treat Cancer

November 12, 2021

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