The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
BUSINESS
Mitsubishi Tanabe’s Oral Edaravone Accepted for FDA Review in ALS
Mitsubishi Tanabe Pharma said on January 13 that an oral suspension version of its ALS therapy Radicava (edaravone) has been accepted by the US FDA for review, with a target date set for May 12 under the priority review pathway.…
To read the full story
Related Article
- US FDA Grants Orphan Exclusivity for ALS Drug Radicava ORS
April 10, 2024
- Oral Radicava Approved in Switzerland: Mitsubishi Tanabe
May 12, 2023
- Canada Approves Mitsubishi Tanabe’s Oral Edaravone for ALS
November 10, 2022
- US FDA OKs Mitsubishi Tanabe’s Oral Edaravone for ALS
May 16, 2022
- Mitsubishi Tanabe’s Oral Edaravone Accepted for Swiss Review in ALS
April 26, 2022
- Mitsubishi Tanabe Eyes US Submission of Oral Edaravone by March-End
December 13, 2021
BUSINESS
- Sanofi Bets on Immunotherapy to Delay Onset of Type 1 Diabetes
December 19, 2025
- Japan’s 1st Eylea Biosimilar to Reach Market on January 7
December 19, 2025
- Datroway Accepted for European Review for 1st Line TNBC
December 19, 2025
- Recordati Snags Japan Rights to BMS’ Myelofibrosis Med Inrebic
December 19, 2025
- Tokyo Court Tosses Nihon Generic’s Suit over Bayer’s Xarelto Patent Communications
December 18, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
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…