Lundbeck Reports the MHLW’s NDA Acceptance of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine

Shots: The Japanese MHLW has accepted an NDA of Vyepti for the treatment of pts living with migraine, who are eligible for preventive therapy; regulatory review is also ongoing in China & South Korea The NDA was supported by extensive clinical data, incl. the P-III (SUNRISE) trial of Vyepti (100 or 300mg, IV) vs PBO…

ByRidhi Rastogi2 days ago

INSIGHTS+

New Drug Designations – September 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 September 2025 report covers designations granted to 33 drugs and 4 medical devices, spanning 12 small molecules, 6 biologics, 8 cell and gene therapies & 4 medical devices among others  …

ByRidhi RastogiOctober 28, 2025

NEWS

Daiichi Sankyo Reports the MHLW’s sNDA Submission of Enhertu + Perjeta to Treat HER2+ Breast Cancer

Shots: Japan’s MHLW has received the sNDA of Enhertu + pertuzumab for the treatment of pts with HER2+ unresectable or recurrent breast cancer sNDA was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta (THP) in HER2+ metastatic breast cancer pts (n=1157), which showed improved PFS by 44%,…

ByRidhi RastogiOctober 7, 2025

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…

ByRidhi RastogiSeptember 23, 2025

NEWS

Novocure Reports MHLW’s Approval of Optune Lua for NSCLC

Shots: Approval of Optune Lua for adults with unresectable advanced/recurrent NSCLC who progressed on Pt-based regimen, was based on P-III (LUNAR) trial assessing it with PD-1/PD-L1 inhibitors or docetaxel (n=145) vs PD-1/PD-L1 inhibitors or docetaxel alone (n=146) Trial showed an mOS (1EP) of 13.2 vs 9.9mos. in the overall population, 19 vs 10.8mos. with Optune Lua +…

ByRidhi RastogiSeptember 16, 2025

NEWS

Bayer Reports the US FDA’s NDA Acceptance of Gadoquatrane for Contrast-Enhanced MRI

Shots: The US FDA has accepted NDA of gadoquatrane (0.04mmol Gd/kg body weight) for contrast-enhanced MRI of the CNS & other body regions (OBR) in adults & pediatric pts incl. neonates; MAA was submitted to MHLW & EMA with further filings planned in other regions NDA was supported by the QUANTI clinical program, which incl.…

ByRidhi RastogiAugust 27, 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…

ByRidhi RastogiAugust 26, 2025

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…

ByRidhi RastogiAugust 25, 2025

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…

ByRidhi RastogiJuly 29, 2025

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  …

ByDipanshu DixitJune 24, 2025

Lundbeck Reports the MHLW’s NDA Acceptance of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine

New Drug Designations – September 2025

Daiichi Sankyo Reports the MHLW’s sNDA Submission of Enhertu + Perjeta to Treat HER2+ Breast Cancer

New Drug Designations – August 2025

Novocure Reports MHLW’s Approval of Optune Lua for NSCLC

Bayer Reports the US FDA’s NDA Acceptance of Gadoquatrane for Contrast-Enhanced MRI

New Drug Designations: July 2025

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

New Drug Designations: June 2025

New Drug Designations – May 2025

Contact US

OUR INFORMATION

FOLLOW US