Bla.

Events

• The FDA is reviewing the BLA submission from Ultragenyx Pharmaceutical, with Eric Crombez serving as chief medical officer.
  Well supported5 reportsUpdated Wednesday
• uniQure N.V. traded on the Nasdaq stock exchange and submitted a Biologics License Application (BLA) for accelerated approval of its gene therapy.
  Some support2 reportsUpdated Wednesday
• Immix Biopharma's drug NXC-201 is seeking BLA approval from the FDA and received Orphan Drug Designation from the EMA.
  Some support2 reportsUpdated Tuesday
• The FDA issued a Complete Response Letter regarding the RP1 BLA to Replimune Group, Inc. on August 7, 2025.
  Well supported11 reportsUpdated Sep 27
• Mesoblast is seeking FDA review of the BLA for its product rexlemestrocel-L.
  Some support2 reportsUpdated Sep 24
• The FDA accepted the Biologics License Application (BLA) under priority review for a drug candidate, apitegromab, developed by Scholar Rock Holding for the treatment of Spinal Muscular Atrophy (SMA).
  Well supported7 reportsUpdated Sep 21
• The General Directorate of Intelligence formalizes arrangements with militant groups BLA and TTP amid separatist violence in Balochistan.
  Some support1 reportUpdated Sep 19
• FDA granted Priority Review for the BLA submission of the SkinTE product.
  Some support2 reportsUpdated Sep 15