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US FDA

Rigel’s R289 Secures the US FDA’s Fast Track Designation for Treating Lower-Risk Myelodysplastic Syndrome

Rigel’s R289 Secures the US FDA’s Fast Track Designation for Treating Lower-Risk Myelodysplastic Syndrome

  • December 3, 2024
Cumberland Pharmaceuticals’ Ifetroban Secures the US FDA’s ODD and RPDD for Duchenne Muscular Dystrophy

Cumberland Pharmaceuticals’ Ifetroban Secures the US FDA’s ODD and RPDD for Duchenne Muscular Dystrophy

  • November 7, 2024
ARTHEx Biotech Secures the US FDA’s Rare Pediatric Designation (RPD) to ATX-01 for Treating Myotonic Dystrophy Type 1 (DM1)

ARTHEx Biotech Secures the US FDA’s Rare Pediatric Designation (RPD) to ATX-01 for Treating Myotonic Dystrophy Type 1 (DM1)

  • November 7, 2024
Jaguar Health Reports the US FDA’s Renewal of Conditional Approval for Canalevia-CA1 to Treat Chemotherapy-Induced Diarrhea in Dogs

Jaguar Health Reports the US FDA’s Renewal of Conditional Approval for Canalevia-CA1 to Treat Chemotherapy-Induced Diarrhea in Dog...

  • November 7, 2024
Insights+: The US FDA New Drug Approvals in July 2024

Insights+: The US FDA New Drug Approvals in July 2024

  • August 13, 2024
Insights+: The US FDA New Drug Approvals in June 2024

Insights+: The US FDA New Drug Approvals in June 2024

  • July 16, 2024
Sanofi Reports the US FDA’s Acceptance & Priority Review of Tolebrutinib for Non-Relapsing Secondary Progressive Multiple Sclerosis

    Sanofi Reports the US FDA’s Acceptance & Priority Review of Tolebrutinib for Non-Relapsing Secondary Progressive Multiple Sclerosi...

    • March 25, 2025
    Newronika

      Newronika's AlphaDBS Receives European CE Mark for Adaptive Deep Brain Stimulation in Parkinson's Disease

      • March 24, 2025
      Moon Surgical Reports US FDA’s 510(k) Clearance of ScoPilot to Improve Intraoperative Capability

        Moon Surgical Reports US FDA’s 510(k) Clearance of ScoPilot to Improve Intraoperative Capability

        • March 21, 2025
        Novartis Reports the US FDA’s Approval of Fabhalta (Iptacopan) to Treat C3 glomerulopathy

          Novartis Reports the US FDA’s Approval of Fabhalta (Iptacopan) to Treat C3 glomerulopathy

          • March 21, 2025
          Alnylam Pharmaceuticals Reports the US FDA’s Approval of Amvuttra (Vutrisiran) to Treat ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)

            Alnylam Pharmaceuticals Reports the US FDA’s Approval of Amvuttra (Vutrisiran) to Treat ATTR Amyloidosis with Cardiomyopathy (ATTR...

            • March 21, 2025
            Orthofix Medical Receives US FDA’s 510(k) clearance & European CE Mark for its TrueLok Elevate Transverse Bone Transport (TBT) System

              Orthofix Medical Receives US FDA’s 510(k) clearance & European CE Mark for its TrueLok Elevate Transverse Bone Transport (TBT) Sys...

              • March 20, 2025
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