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Breakthrough Therapy Designation

Genentech's Gantenerumab Receives the US FDA's Breakthrough Therapy Designation for the Treatment of Alzheimer's Disease

Genentech's Gantenerumab Receives the US FDA's Breakthrough Therapy Designation for the Treatment of Alzheimer's Disease

  • October 11, 2021
Hutchmed's Amdizalisib (HMPL-689) Receives Breakthrough Therapy Designation for the Treatment of R/R Follicular Lymphoma in China

Hutchmed's Amdizalisib (HMPL-689) Receives Breakthrough Therapy Designation for the Treatment of R/R Follicular Lymphoma in China

  • September 13, 2021
Boehringer Ingelheim and Eli Lilly's Jardiance (empagliflozin) Receive the US FDA's Breakthrough Therapy Designation for the Treatment of Heart Failure with Preserved Ejection Fraction

Boehringer Ingelheim and Eli Lilly's Jardiance (empagliflozin) Receive the US FDA's Breakthrough Therapy Designation for the Treat...

  • September 10, 2021
Junshi and Coherus's Toripalimab Receive the US FDA's Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma

Junshi and Coherus's Toripalimab Receive the US FDA's Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma

  • August 13, 2021
Takeda's TAK-994 Receives Breakthrough Therapy Designation for the Treatment of Narcolepsy Type 1

Takeda's TAK-994 Receives Breakthrough Therapy Designation for the Treatment of Narcolepsy Type 1

  • July 29, 2021
Genentech's Venclexta (venetoclax) + Azacitidine Receives Breakthrough Therapy Designation for the Treatment of Myelodysplastic Syndromes

Genentech's Venclexta (venetoclax) + Azacitidine Receives Breakthrough Therapy Designation for the Treatment of Myelodysplastic Sy...

  • July 21, 2021
New Drug Designations - October 2024

    New Drug Designations - October 2024

    • November 26, 2024
    InxMed’s Ifebemtinib Secures the NMPA’s Breakthrough Therapy Designation as a 1L Treatment of KRAS G12C Mutated NSCLC

      InxMed’s Ifebemtinib Secures the NMPA’s Breakthrough Therapy Designation as a 1L Treatment of KRAS G12C Mutated NSCLC

      • November 21, 2024
      New Drug Designations - September 2024

        New Drug Designations - September 2024

        • October 29, 2024
        Dizal’s Sunvozertinib Receives the NMPA’s Breakthrough Therapy Designation as a 1L Treatment of NSCLC with EGFR Mutations

          Dizal’s Sunvozertinib Receives the NMPA’s Breakthrough Therapy Designation as a 1L Treatment of NSCLC with EGFR Mutations

          • October 15, 2024
          Zealand Pharma and Boehringer Ingelheim Report the US FDA’s Breakthrough Therapy Designation of Survodutide for MASH

            Zealand Pharma and Boehringer Ingelheim Report the US FDA’s Breakthrough Therapy Designation of Survodutide for MASH

            • October 8, 2024
            Sagimet’s Denifanstat Gains the US FDA’s Breakthrough Therapy Designation to Treat Noncirrhotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)

              Sagimet’s Denifanstat Gains the US FDA’s Breakthrough Therapy Designation to Treat Noncirrhotic Metabolic Dysfunction-Associated S...

              • October 3, 2024
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