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REGULATORY
- Herceptin’s Salivary Cancer Use Sails through PAFSC; Label Expansions for I/O Drugs, Lorbrena in Line for Approval
November 5, 2021
- Ronapreve Clears Key Panel for COVID-19 Prevention, SC Use
November 5, 2021
- Pfizer’s COVID-19 Booster Up for PAFSC Review on Nov. 10
November 5, 2021
- Booster Shots to Start with Pfizer Vaccine: MHLW
November 2, 2021
- G20 Ministers Vow to Boost Vaccine Supply to Developing Countries
November 2, 2021
- Noda, Tokashiki, More in LDP Healthcare Clique Lose Seats in Lower House Poll
November 1, 2021
- Japan Panel OKs Booster Shots for All People Who Took 2 Doses
October 29, 2021
- Late-Phase Trials with Overseas Participation Pragmatic Approach for Japan-Made COVID-19 Vaccine Development: PMDA Director
October 29, 2021
- Ronapreve Up for PAFSC Review for Preventive Use on Nov. 4
October 29, 2021
- Japan to Compile Emergency Proposal for Economic Security in Early November
October 27, 2021
- Health Minister Vows Early Approval of Oral COVID-19 Drugs
October 27, 2021
- Industry Calls for Simplifying Regulatory Process for SaMD
October 26, 2021
- Lilly’s Migraine Drug Lasmiditan, Jardiance’s Heart Failure Use Up for PAFSC Review on Nov. 5
October 26, 2021
- PMDA Issues Guidance on COVID-19 Vaccines’ Immunogenicity Assessment for Non-Placebo-Controlled Trials
October 25, 2021
- MHLW Panels Continue to See No Major Safety Concerns for COVID-19 Jabs
October 25, 2021
- MHLW Proposes Further Measures to Promote Generics in Basic Plan for FY2022 Reimbursement Reform
October 25, 2021
- MHLW Panel OKs 81 More COVID-19 Vaccine Health Damage Claims
October 25, 2021
- Tecentriq under PMDA Safety Review for Cholangitis Sclerosing
October 25, 2021
- Herceptin’s Salivary Cancer Use Up for PAFSC Review on Nov. 4; Label Expansions for I/O Drugs, Lorbrena on Agenda Too
October 22, 2021
- Chuikyo Discusses Spillover Rules in Market Expansion Re-Pricing, PMP Criteria towards FY2022 Reform
October 21, 2021
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