“We thank the agency for their collaborative approach. The responses and guidance from FDA are clear and provide us with a high level of confidence to refile our BLA for remestemcel-L in children with SRaGVHD,” said Mesoblast CEO Dr Silviu Itescu.
Investors welcome Mesoblast update and pathway for resubmission to FDA
April 3, 2024 Australian Biotech
Latest Video
New Stories
-
It is profoundly wrong for any system to exclude compassion while outsourcing it to others
March 16, 2026 - - Latest News -
Scientists identify highly specific targets that could transform multiple myeloma treatment
March 15, 2026 - - Australian Biotech -
CSL Seqirus' adjuvanted flu vaccine approval extended to Australians aged 50 and over
March 15, 2026 - - Latest News -
GSK claims Pharma Cup as Kosi Challenge surpasses fundraising record
March 15, 2026 - - Latest News -
New program aims to make women’s health care more affordable and accessible
March 13, 2026 - - Latest News -
Australians turn to local pharmacies as frontline of everyday healthcare
March 13, 2026 - - Latest News -
Sandoz and Camp Quality unite to strengthen support for Australian families facing childhood cancer
March 13, 2026 - - Latest News

