The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
BUSINESS
FDA Clears Orchard’s Lenmeldy Gene Therapy for MLD
Orchard Therapeutics, now a Kyowa Kirin company, has earned US regulatory approval for Lenmeldy (atidarsagene autotemcel), a gene therapy for the treatment of children with early-onset metachromatic leukodystrophy (MLD). Previously known as OTL-200, Lenmeldy was approved by the FDA on…
To read the full story
Related Article
- Kyowa Kirin Closes Acquisition of UK Gene Therapy Player Orchard
January 25, 2024
- Kyowa Kirin Set to Gain Tens of Billions of Yen in Sales from Orchard Acquisition
October 20, 2023
- Kyowa Kirin to Acquire Orchard to Forge Ahead in Gene Therapy
October 6, 2023
BUSINESS
- Cyto-Facto Expands CPC Footprint to Win Multiple Cell Therapy Contracts
December 24, 2025
- Shionogi, Salubritas Tie Up on Hair Cell Regeneration R&D for Hearing Loss
December 24, 2025
- Guardant360 Approved in Japan as CDx for Lilly’s Inluriyo
December 24, 2025
- Meiji Pharma Sets Up Singapore Unit to Bolster ASEAN Push
December 24, 2025
- Santen Releases VKC Eye Drop Verkazia in China
December 24, 2025
Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…
Novartis’ Pluvicto (lutetium vipivotide tetraxetan (177Lu)) won reimbursement listing in Japan in November as a radioligand therapy (RLT) for PSMA-positive…
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…