Drug Approval & Reimbursement in 2025

• Chuikyo OKs Listing of Novartis’ Pluvicto, Peak Sales Outlook at 42.1 Billion Yen
  November 6, 2025

• Chuikyo Clears Listing for Yorvipath and More Drugs; Zero Premium Rule Weighs Yet Again
  October 16, 2025

• Listing OK’ed for Krystal’s Vyjuvek Gel, Japan’s First Topical Gene Therapy
  October 16, 2025

• Japan Approves Pluvicto, Izervay, and Lots More; Subcutaneous Rybrevant Not on Roster
  September 22, 2025

• Susmed Wins Partial Change Approval for Insomnia App, Seeks Coverage
  September 8, 2025

• Takeda Wins Japan Approval for Takhzyro Pen Formulation
  September 2, 2025

• Meiji Bags Japan Approval for 2-Dose COVID Vaccine Vial
  September 1, 2025

• LP.8.1-Tailored Nuvaxovid COVID Jab Approved in Japan: Takeda
  August 28, 2025

• Japan Approves 3 New Drugs, Expands Label for Enhertu, Silgard 9 and More
  August 26, 2025

• Japan Approves Roche Diagnostics Test for HER2 Ultralow Breast Cancer
  August 26, 2025

• Japan Approves First SGLT2 Generics, 12 Firms Pile into Vimpat Ahead of December Listing
  August 18, 2025

• Japan Approves Pfizer/BioNTech’s LP.8.1-Tailored COVID Vaccines
  August 12, 2025

• Japan Approves MSD’s 21-Valent Pneumococcal Vaccine
  August 8, 2025

• Welireg, Airwin, Talvey and More Set for NHI Listing; Premiums Wiped Out by “Zero” Rule
  August 7, 2025

• Japan Approves Updated Spikevax for LP.8.1 Omicron Strain
  August 6, 2025

• Krystal Biotech Snags Japan Nod for Vyjuvek as 1st Topical Gene Therapy
  July 29, 2025

• Janssen’s Balversa Gets Green Light for NHI Listing
  July 10, 2025

• Kyowa Kirin Wins Japan Nod for Lumicef Pen Injector
  June 27, 2025

• Japan Approves Crysvita Prefilled Syringe: Kyowa Kirin
  June 26, 2025

• Japan Approves MSD’s Airwin/Welireg, J&J Bispecific, and More
  June 25, 2025

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