🇺🇸 TAFASITAMAB in United States

FDA authorised TAFASITAMAB on 18 June 2025 · 2,287 US adverse-event reports

Marketing authorisation

FDA — authorised 18 June 2025

  • Application: BLA761163
  • Marketing authorisation holder: MORPHOSYS US INC
  • Indication: Efficacy
  • Status: approved

The FDA approved TAFASITAMAB for its efficacy in a marketing authorisation application (BLA761163) submitted by MORPHOSYS US INC. This approval was granted on 18 June 2025. The local brand name for TAFASITAMAB is not reported.

Read official source →

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. Disease Progression — 660 reports (28.86%)
  2. Diffuse Large B-Cell Lymphoma — 375 reports (16.4%)
  3. Off Label Use — 343 reports (15%)
  4. Lymphoma — 206 reports (9.01%)
  5. Death — 173 reports (7.56%)
  6. Neutropenia — 131 reports (5.73%)
  7. Covid-19 — 118 reports (5.16%)
  8. Drug Ineffective — 101 reports (4.42%)
  9. Pneumonia — 93 reports (4.07%)
  10. General Physical Health Deterioration — 87 reports (3.8%)

Source database →

TAFASITAMAB 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 TAFASITAMAB approved in United States?

Yes. FDA authorised it on 18 June 2025.

Who is the marketing authorisation holder for TAFASITAMAB in United States?

MORPHOSYS US INC holds the US marketing authorisation.