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INSIGHTS+

New Drug Designations – August 2025     

Shots:      PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA    The August 2025 report covers designations granted to 37 drugs and 4 medical devices, spanning 14 small molecules, 5 biologics, 7 cell and gene therapies & 4 medical devices, among others    Significant…
September 23, 2025

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New Drug Designations: July 2025
INSIGHTS+

New Drug Designations: July 2025

Shots:       PharmaShots’ Designation Report offers a concise overview of the latest drug and device designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA.    The July 2025 edition covers designations awarded to 47 drugs and 3 medical devices, comprising 23 small molecules, 9 biologics, 8 cell and gene therapies, and…
August 26, 2025

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Daiichi Sankyo
NEWS

Daiichi Sankyo Reports the MHLW’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Shots: Japan’s MHLW has approved Enhertu monotx. for inoperable HR+, HER2-low/ultralow MBC whose disease progressed on & are ineligible for endocrine therapy Approval was based on the P-III (DESTINY-Breast06) trial (N=866) assessing Enhertu (5.4mg/kg) vs CT in HER2-low (n=713) & ultralow (n=152) pts Trial showed 38% PFS in CT-naïve HER2-low pts & mPFS of 13.2…
August 25, 2025

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INSIGHTS+

New Drug Designations: June 2025 

Shots:      PharmaShots’ Designation Report offers a concise overview of the latest drug and device designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA   The June 2025 edition covers designations awarded to 43 drugs and 3 medical devices, comprising 17 small molecules, 7 biologics, 8 cell and gene therapies, and…
July 29, 2025

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INSIGHTS+

New Drug Designations – May 2025  

Shots:      PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada and NMPA    The May 2025 report covers designations granted to 44 drugs and 5 medical devices, spanning 15 small molecules, 7 biologics, 13 cell and gene therapies & 5 medical devices among others   …
June 24, 2025

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GSK New
NEWS

GSK Reports the MHLW’s sNDA Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: Japan’s MHLW has accepted sNDA of Arexvy RSV vaccine for adults aged 18-49yrs. at increased risk, expanding its use beyond those aged ≥50yrs. Submission was based on P-IIIb trial (n=1458) assessing non-inferiority & safety of Arexvy RSV vaccine in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429); an additional cohort (18-49yrs.; n=603) was followed for…
June 20, 2025

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INSIGHTS+

New Drug Designations – April 2025  

Shots:     PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada and NMPA   The April 2025 report covers designations granted to 36 drugs and 6 medical devices, spanning 14 small molecules, 3 biologics, 11 cell and gene therapies & 6 medical devices among…
May 27, 2025

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GSK New
NEWS

GSK Receives the MHLW’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Shots: MHLW has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy; review ongoing in the US (PDUFA: Jul 23, 2025), EU, Canada, China (PR for DREAMM-7), & Switzerland (with PR for DREAMM-8) Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep (2.5mg/kg, IV, Q3W) + BorDex vs Darzalex + BorDex in 494…
May 19, 2025

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