Urothelial Carcinoma

• EMA approval · 2026-04-22
  EMA Authorised: Keytruda (pembrolizumab) — Merck Sharp & Dohme B.V.

  The European Medicines Agency authorised Keytruda (pembrolizumab) for multiple cancer indications, including melanoma, Hodgkin lymphoma, ren…

• EMA approval · 2026-03-30
  EMA Authorised: Tecentriq (atezolizumab) — Roche Registration GmbH

  The European Medicines Agency authorized Tecentriq (atezolizumab) by Roche Registration GmbH for multiple cancer indications, including non-…

• EMA approval · 2026-03-18
  EMA Authorised: Opdivo (nivolumab) — Bristol-Myers Squibb Pharma EEIG

  EMA authorised Opdivo (nivolumab) for multiple cancer indications, including melanoma, Hodgkin lymphoma, renal cell carcinoma, non-small cel…

• FDA approval · 2025-11-21
  FDA Approved: PADCEV EJFV — Supplemental Application (SEAGEN INC.)

  The FDA approved a supplemental application for PADCEV EJFV (enfortumab vedotin) filed by Seagen Inc., resulting in an updated labeling for …

• FDA approval · 2025-10-17
  FDA Approved: BALVERSA — Supplemental Application (Janssen Products LP)

  FDA approved a supplemental application for BALVERSA (erdafitinib) from Janssen Products LP.

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• EMA approval · 2025-09-25
  EMA Authorised: Padcev (Enfortumab vedotin) — Astellas Pharma Europe B.V.

  The European Medicines Agency authorised Padcev (enfortumab vedotin) for urothelial carcinoma and other urologic neoplasms in the European U…

• EMA approval · 2025-07-16
  EMA Authorised: Javlor (vinflunine) — Pierre Fabre Medicament

  The European Medicines Agency authorised Javlor (vinflunine) from Pierre Fabre Medicament for transitional cell carcinoma of the urothelium …

• FDA approval · 2025-02-27
  FDA Approved: PADCEV EJFV — Supplemental Application (SEAGEN INC.)

  The FDA has approved a supplemental application for PADCEV EJFV (enfortumab vedotin) from Seagen, marking regulatory action on a supplementa…

• FDA approval · 2024-10-09
  FDA Approved: BALVERSA — Supplemental Application (Janssen Products LP)

  The FDA approved a supplemental application for BALVERSA (erdafitinib) submitted by Janssen Products LP.

• FDA approval · 2024-01-19
  FDA Approved: BALVERSA — Supplemental Application (Janssen Products LP)

  The FDA approved a supplemental application for BALVERSA (erdafitinib) submitted by Janssen Products LP.

• FDA approval · 2023-04-03
  FDA Approved: PADCEV EJFV — Supplemental Application (SEAGEN INC.)

  FDA approved a supplemental application for PADCEV (enfortumab vedotin) submitted by Seagen Inc. This document communicates the FDA's approv…

• FDA approval · 2023-03-20
  FDA Approved: BALVERSA — Supplemental Application (Janssen Products LP)

  The FDA approved a supplemental application for Balversa (erdafitinib) submitted by Janssen Products LP.

• FDA approval · 2023-01-11
  FDA Approved: BALVERSA — Supplemental Application (Janssen Products LP)

  FDA approves a supplemental application for BALVERSA (erdafitinib) submitted by Janssen Products LP.

• FDA approval · 2022-10-28
  FDA Approved: PADCEV EJFV — Supplemental Application (SEAGEN INC.)

  FDA approved a supplemental application for PADCEV EJFV (enfortumab vedotin) by Seagen.

• FDA approval · 2022-04-27
  FDA Approved: BALVERSA — Supplemental Application (Janssen Products LP)

  The FDA approved a supplemental application for BALVERSA (erdafitinib) submitted by Janssen Products LP.

• FDA approval · 2021-07-09
  FDA Approved: PADCEV EJFV — Supplemental Application (SEAGEN INC.)

  FDA approved a supplemental application for PADCEV EJFV (enfortumab vedotin) from Seagen, indicating an approved update to its labeling.

• FDA approval · 2021-03-22
  FDA Approved: PADCEV EJFV — Supplemental Application (SEAGEN INC.)

  FDA has approved a supplemental application for PADCEV EJFV (enfortumab vedotin) from Seagen, indicating an approved supplemental action rel…

• FDA approval · 2020-06-30
  FDA Approved: BAVENCIO — Supplemental Application (EMD Serono, Inc.)

  FDA approved a supplemental application for BAVENCIO (avelumab) submitted by EMD Serono, Inc. This entry serves as the official notice of th…

• FDA approval · 2020-04-02
  FDA Approved: BALVERSA — Supplemental Application (Janssen Products LP)

  The FDA approved a supplemental application for BALVERSA (erdafitinib) from Janssen Products LP, resulting in labeling changes (potentially …

• FDA approval · 2019-12-18
  FDA Approved: PADCEV EJFV — Original Application (SEAGEN INC.)

  The FDA approved PADCEV EJFV (enfortumab vedotin) from Seagen in its original application, marking the product's initial regulatory clearanc…

• FDA approval · 2019-04-12
  FDA Approved: BALVERSA — Original Application (Janssen Products LP)

  The FDA documents the original approval of BALVERSA (erdafitinib) by Janssen Products LP for urothelial carcinoma with FGFR genetic alterati…

• CLINICAL_TRIALS approval · 2016-11-02
  Clinical Trial Update: An Expanded Access Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy

  Expanded-access update for atezolizumab in locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy, with …

• FDA approval · 2016-05-18
  FDA Approved: TECENTRIQ — Original Application (Genentech, Inc.)

  This FDA page documents the original Biologics License Application approval of Tecentriq (atezolizumab) from Genentech, marking the first FD…