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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
October 11, 2021
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 Treat...
September 10, 2021
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
July 29, 2021
Genentech's Venclexta (venetoclax) + Azacitidine Receives Breakthrough Therapy Designation for the Treatment of Myelodysplastic Sy...
July 21, 2021
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
October 29, 2024
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
October 8, 2024
Sagimet’s Denifanstat Gains the US FDA’s Breakthrough Therapy Designation to Treat Noncirrhotic Metabolic Dysfunction-Associated S...
October 3, 2024
GSK’s Blenrep Combination Gains the NMPA’s Breakthrough Therapy Designation to Treat R/R Multiple Myeloma
September 13, 2024
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