Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
FDA Accepts Leqembi SC for Review; Target Date Set to Aug. 31
Eisai said on January 14 that the US FDA has accepted for regulatory review its application for a subcutaneous autoinjector version of Leqembi (lecanemab) as a weekly maintenance treatment for early Alzheimer’s disease. The target action date under the Prescription…
To read the full story
Related Article
- Leqembi Iqlik Now Available for Alzheimer’s Initiation Use in US
August 25, 2026
- FDA Greenlights Leqembi Iqlik for Alzheimer’s Initiation Therapy
July 14, 2026
- FDA Delays Review of Leqembi Iqlik for Alzheimer’s Initiation Therapy
May 11, 2026
- Leqembi Iqlik Now under FDA Review for Initiation Phase
January 26, 2026
- Leqembi Iqlik Autoinjector Now Available in US: Eisai/Biogen
October 8, 2025
- Eisai Begins FDA Rolling Submission for Leqembi SC for Starting Dose
September 4, 2025
- FDA Clears Leqembi Autoinjector; Launch Set for Oct. 6
September 2, 2025
- FDA Rolling Submission for Leqembi SC Completed: Eisai
November 5, 2024
- Eisai Begins Rolling Submission for Subcutaneous Leqembi in US
May 16, 2024
BUSINESS
- Lunsumio Combo Hits PIII Goal in Follicular Lymphoma: Roche
September 18, 2026
- Padcev-Keytruda Gets CHMP Nod for Expanded MIBC Use
September 18, 2026
- SanBio Eyes October Start for Akuugo Treatment
September 18, 2026
- Toho Unit to Launch Pharma-Wholesaler Payment Service
September 18, 2026
- Astellas Names Marino General Counsel, Compliance Chief
September 18, 2026
Japan is ramping up its push to spread regional formularies nationwide, a policy expected to standardize treatments, strengthen supply resilience,…
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…