REGULATORY
J&J’s Subcutaneous Rybrevant Faces Delay in Japan Approval Process
Japan's approval procedure for Janssen Pharmaceutical’s (J&J) subcutaneous formulation of Rybrevant (amivantamab) has been pushed back after the drug was unexpectedly left off the agenda of a health ministry council meeting this month. The product combines Rybrevant with recombinant hyaluronidase…
To read the full story
Related Article
- Data Error Delayed Japan Review of Subcutaneous Rybrevant; Approval Still Expected This Year
October 30, 2025
- J&J Files for 4-Week SC Dosing of Rybrevant in Japan
October 28, 2025
- Japan Approves Pluvicto, Izervay, and Lots More; Subcutaneous Rybrevant Not on Roster
September 22, 2025
- Novartis’ Radioligand Therapy, More Meds Inch Closer to Japan Approval with Panel OK
August 25, 2025
REGULATORY
- Celltrion’s Eylea Biosimilar Nears Approval, but Listing Outlook Clouded
February 27, 2026
- Japan Panel to Review Joenja, Dojolvi for Approval at March 5 Session
February 27, 2026
- Executives Urge Stronger CDMO, CRO Base at Drug Discovery WG Meeting
February 27, 2026
- Japan to Closely Monitor US “MFN” Policy: PM Takaichi
February 27, 2026
- Japan to Update Adult Pneumococcal Fact Sheet Ahead of Capvaxive NIP Review
February 27, 2026
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…





