The FDA issued recommendations for a BLA submission regarding a global Phase 3 study conducted by Larimar Therapeutics, utilizing the START pilot program.

The entities involved

• FDA →
  • Generic medicine services are seeking approval for launch from the FDA.Mon 17:49
  • A company is seeking FDA feedback on its NEO212 program, with a meeting scheduled at the FDA's White Oak campus.Mon 14:56
• Start →

  Nothing else this week.

• Europe →

  terrestrial continent located in north-western Eurasia

  • The European Commission aims to strengthen homegrown AI capabilities while global advanced models face usage restrictions.Mon 17:49
  • The European Central Bank is forced to raise interest rates due to energy price shocks from the Iran war and an influx of Chinese exports.Mon 17:49
• U.K. →
  • UK police are currently investigating plots targeting Iran.Mon 17:18
  • Cornell researchers, including Pei Zhou, applied a scoring system originating from the U.K.Mon 16:38

Related events

• TELIX Pharmaceuticals is conducting Phase 3 trials and seeking alignment on the New Drug Application pathway with the FDA.Sep 2
• FDA provided responses to a Type B meeting request and Oragenics conducted a Phase IIa trial in Australia.Aug 28
• Mesoblast is seeking FDA review of the BLA for its product rexlemestrocel-L.Jul 1
• MAIA Biotechnology, Inc. is actively enrolling patients and expanding its pivotal Phase 3 clinical trials across multiple nations, including Europe, Spain, Hungary, and Portugal.Sep 23
• OS Therapies, Inc. is seeking interim and final review data submissions from regulatory bodies while attending major global investment conferences.Sep 2