REGULATORY

• J&J’s Lazcluze, Genmab’s Tivdak, and More Up for MHLW Panel Review on Feb. 27
  February 14, 2025

• Japan Cabinet Approves Bill to Amend PMD Act
  February 13, 2025

• MHLW Not Yet Able to Examine Letters of Protest by US Lobbies: Minister
  February 13, 2025

• Set Deadline for Non-Prescription Pilot of Morning-After Pill: Panel Members
  February 13, 2025

• MHLW Panel Wary of Non-Prescription Switches for Diquas, Mucosta
  February 13, 2025

• More Flu Drugs Returned than Supplied in Japan: Final Week of January
  February 12, 2025

• PMDA to Modify Onsite GCP Inspections Based on Facility Track Records
  February 10, 2025

• PMDA Reviewing Safety Risks for Immune Checkpoint Inhibitors, CAR-Ts
  February 10, 2025

• Shionogi’s ADHD Game Therapy, CureApp’s Alcoholism App in Line for Approval
  February 7, 2025

• Drug Ecosystem Budget Project Is for Private Sector: Minister
  February 7, 2025

• Japan’s 1st Hemophilia B Gene Therapy Up for Panel Review on Feb. 19
  February 6, 2025

• PMD Act Set for Amendments Covering Issues Unaddressed over Past Decade: MHLW Official
  February 4, 2025

• Council OKs Public Knowledge Application for CellCept Label Expansion
  February 3, 2025

• LDP OKs Govt’s 5-Year Healthcare Strategy with “Expanding Ecosystems” as Main Pillar
  February 3, 2025

• Lixiana Now Set for Label Expansion; 11 Drugs to Get Orphan Tags
  February 3, 2025

• CSL’s HAE Drug, Tecentriq Sarcoma Use Clear Panel Review; February Approval Expected
  January 31, 2025

• MHLW to Take Balanced Approach in Dealing with Off-Year Revisions: Minister
  January 31, 2025

• MHLW Orders Label Revisions for Lixiana, Keytruda, and More Drugs
  January 30, 2025

• Pfizer’s Litfulo Braced for Price Cut after Cost-Effectiveness Assessment
  January 30, 2025

• MHLW Panel Finalizes NIP Inclusion of Shingles Jabs, OKs New Basic Immunization Plan
  January 30, 2025

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