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Important announcement

🚨NEWS🚨

@EMA_News recommends conditional marketing authorization for belumosudil, a ROCK2 inhibitor, for the treatment of cGvHD in patients aged ≥12 yrs (≥40 kg) with inadequate response to other therapies.

Read more: https://bit.ly/4qiXap1
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More drug updates

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Important announcement
🚨NEWS🚨 British Columbia and Ontario add belumosudil, a ROCK1/2 inhibitor, to their provincial formularies for the treatment of adult and pediatric patients aged ≥12 years with chronic #GvHD after ≥2 lines of therapy. Read more: https://bit.ly/4rvC1cc
Feb 4, 2026
Important announcement
@EMA_News has granted orphan drug designation to RLS-0071 (pegtarazimod) for the treatment of #GvHD, based on preliminary data from an ongoing phase II study including patients with SR-aGvHD. Read more: https://loom.ly/Ozl53ck
Aug 22, 2025
MaaT013 marketing authorization application
MaaT013 marketing authorization application
On June 2, 2025, a marketing authorization application was submitted to the @EMA_News for MaaT013, a pooled fecal microbiota product, for the treatment of gastrointestinal acute #GvHD. This follows positive data from the Pivotal ARES study. Read more: https://businesswire.com/news/home/20250602568637/en/MaaT-Pharma-Advances-Toward-Commercialization-And-Submits-Marketing-Authorization-Application-to-the-European-Medicines-Agency-EMA-for-Xervyteg-MaaT013-in-Acute-Graft-versus-Host-Disease
Jun 4, 2025
Important announcement
On March 11, 2025, the EMA Pediatric Committee provided a positive opinion and cleared the pediatric investigation plan to assess MaaT013 in patients from 6 years old to <18 years old with aGvHD. The study is planned to start in 2026. Read more: https://businesswire.com/news/home/20250311353696/en/MaaT-Pharma-Receives-Positive-Opinion-from-EMA-Pediatric-Committee-on-the-Pediatric-Investigation-Plan-for-MaaT013
Mar 13, 2025