REGULATORY

• Two iPSC-Derived Products Now in Line for Conditional Approval
  February 20, 2026

• PM Takaichi Keeps Cabinet Intact after Lower House Vote
  February 18, 2026

• LDP Returnees Set Sights on Social Security, Drug Policy as Special Diet Opens
  February 18, 2026

• 10 Firms Win Approval for Bilanoa Generics, 2 Contenders for Fycompa
  February 17, 2026

• MHLW to Brand OTC-Like Drug Cost Rule as “Partially Non-Insured Care”
  February 17, 2026

• Taiyo Pharma’s Propranolol Designated as Drug for Specific Use
  February 17, 2026

• Japan Grants Orphan Tag to Bayer, Incyte Drugs, and 12 Others
  February 17, 2026

• Japan to Delist 387 Drugs from NHI Price List, Including Renivace
  February 16, 2026

• Chuikyo Payers Signal Mixed Views on Off-Year Drug Price Revisions
  February 16, 2026

• Chuikyo Issues FY2026 Fee Revision Recommendation, Creates New Premiums for Generics and Biosimilars
  February 16, 2026

• Japan Panel to Review Sumitomo, Cuorips iPSC Products on Feb. 19
  February 16, 2026

• DMD Gene Therapy Elevidys Cleared for NHI Listing at 305 Million Yen
  February 13, 2026

• MHLW Orders Label Revisions for Vyxeos, Inlyta, Imbruvica, and More Drugs
  February 13, 2026

• MHLW Orders Label Revisions for Sulfite-Containing Medical Products
  February 13, 2026

• PMDA Urges Proper Use of Colchicine, Advises against High-Dose Administration
  February 12, 2026

• PMDA to Offer Priority Consultations for Overseas Startups
  February 12, 2026

• Japan OKs 2nd OTC Emergency Contraceptive, Launch Set for March 9
  February 12, 2026

• LDP Wins Landslide Victory in Lower House Election; Ex-Lawmakers Return as Centrists Routed
  February 9, 2026

• MHLW Panel Deems 10 “Drug Loss” Products as High-Need, to Seek Development
  February 9, 2026

• MHLW to Allow OTC Drugs to Match Prescription Doses under Specific Conditions
  February 5, 2026

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