🇺🇸 Cell therapy in United States

13 US adverse-event reports

Marketing authorisation

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Cytokine Release Syndrome — 3 reports (23.08%)
  2. Immune Effector Cell-Associated Neurotoxicity Syndrome — 2 reports (15.38%)
  3. Abasia — 1 report (7.69%)
  4. Asthenia — 1 report (7.69%)
  5. Atrial Fibrillation — 1 report (7.69%)
  6. Brain Oedema — 1 report (7.69%)
  7. Diffuse Large B-Cell Lymphoma Recurrent — 1 report (7.69%)
  8. Headache — 1 report (7.69%)
  9. Lactic Acidosis — 1 report (7.69%)
  10. Lymphocyte Adoptive Therapy — 1 report (7.69%)

Source database →

Cell therapy in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Cell therapy approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Cell therapy in United States?

Pluristem Ltd. is the originator. The local marketing authorisation holder may differ — check the official source linked above.