REGULATORY

• Japan Doles Out Orphan Tags for 10 APIs, Pulls Status for Biogen’s MS Drug
  August 29, 2024

• Japan Approves Label Expansions for Alecensa, Nucala and More
  August 29, 2024

• Panel Conditionally OKs Change to Allow Use of Abortion Pill at Clinics Without Beds
  August 28, 2024

• Japan Panel Clears Amgen’s TED Med, Rexulti for Alzheimer’s Agitation and More
  August 28, 2024

• High-Dose Mecobalamin Now in Line to Become Japan’s 1st ALS Med in 9-Plus Years
  August 28, 2024

• MHLW Sets Global Health Vision to Enhance Drug Innovation Ecosystem
  August 28, 2024

• Sakigake Tags Granted to GSK’s Bepirovirsen, Boehringer’s Nerandomilast
  August 28, 2024

• MHLW to Address Drug Loss, Generic Industry Reform in FY2025 Budget Request
  August 26, 2024

• Astellas Pharma Employee Indicted in China
  August 23, 2024

• New LDP Study Group Seeks Budget to Bolster Immunoglobulin Production
  August 23, 2024

• BMS’ ROS1 Inhibitor, Janssen’s Bispecific Up for Review on Aug. 30
  August 20, 2024

• Kobayashi Declares Bid for LDP Race, Urges More Investment in Pharma
  August 20, 2024

• MHLW to Present Detailed Criteria for Exclusion from “Specified Clinical Trials”
  August 20, 2024

• Certain Jabs to Be Exempted from Regenerative Medicine Safety Act to Facilitate Travel Vaccination
  August 20, 2024

• Xarelto Copycats Earn Blessing, AG Might also Get on Board
  August 19, 2024

• Eisai’s ALS Therapy, Amgen’s TED Drug Up for Review on Aug. 26
  August 19, 2024

• August Generic Approval List Includes AGs for at Least 3 APIs, Acofide and More
  August 19, 2024

• Japan Approves Equa, Onglyza Generics towards December Listing, 1st DPP-4 Copycat on Horizon?
  August 19, 2024

• MHLW Announces Simplified New Process for Drug Delisting
  August 19, 2024

• JGA Shares Scheme of Supply Managers Council, MHLW Conferring with FTC on Feasibility
  August 9, 2024

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