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NEWS

Lundbeck Reports the MHLW Approval of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine

Shots: The Japanese MHLW has approved Vyepti (eptinezumab) for the prevention of migraine attacks in adults Approval was backed by extensive clinical data, incl. P-III (PROMISE-1, PROMISE-2 & DELIVER) studies as well as P-III (SUNRISE) trial, which assessed Vyepti in a predominantly Asian population; NDA was further supported by the SUNSET LTE trial conducted in Japanese…
September 16, 2026

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GSK
NEWS

Japan’s MHLW Approves GSK’s Shingrix PFS Presentation to Protect Individuals Against Shingles

Shots: Japan’s MHLW has approved Shingrix in a PFS format (Recombinant Zoster Vaccine or RSV) for the prevention of shingles (herpes zoster)    Approval was based on technical comparability between the PFS & existing vaccine presentation; the new presentation does not involve a change in indication or dosing Shingrix combines glycoprotein E with the AS01B…
September 10, 2026

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NEWS

Belite Bio Submits NDA to Japan’s MHLW for Tinlarebant in Stargardt Disease Type 1

Shots: Belite Bio submitted a New Drug Application (NDA) to Japan’s MHLW for once-daily oral tinlarebant (LBS-008) for the treatment of Stargardt disease type 1 (STGD1) The NDA was submitted under Japan’s Sakigake Designation System, following tinlarebant’s designation as a Sakigake pharmaceutical product; if approved, it could become the first approved treatment for STGD1 and…
September 8, 2026

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Samsung Bioepis
NEWS

Samsung Bioepis Reports MHLW Approval of its Ustekinumab Biosimilar

Shots: The MHLW has granted marketing approval to Ustekinumab BS IV infusion 130mg 「NIPRO」, a biosimilar version of Stelara (ustekinumab), for induction therapy in mod. to sev. active Crohn’s disease when other treatments are ineffective Additionally, the MHLW approved Ustekinumab BS SC Injection 45mg Syringes 「NIPRO」in Dec 2025, which was then launched in May 2026  The biosimilar…
September 4, 2026

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BioCryst
NEWS

BioCryst Pharmaceuticals Reports MHLW Approval of Orladeyo for Hereditary Angioedema

Shots: The MHLW has approved Orladeyo (berotralstat) for prophylactic therapy in pediatric pts (2 to <12 yrs.) with hereditary angioedema (HAE) Approval was based on interim APeX-P trial results in pediatric pts with HAE, which showed early & sustained reductions in monthly attack rates; published in the Annals of Allergy, Asthma & Immunology BioCryst plans to launch…
August 26, 2026

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NEWS

Oncolys BioPharma Reports MHLW Approval of Telomelysin for Esophageal Cancer

Shots: The Japanese MHLW has granted full marketing approval to Telomelysin Injection (suratadenoturev/OBP-301) for the treatment of esophageal cancer pts ineligible for curative resection or CT, based on a Japanese pivotal trial conducted at 17 sites Approval triggered a milestone payment to Oncolys under its deal with FUJIFILM Toyama Chemical, which granted FUJIFILM commercialization rights…
June 10, 2026

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