Basal Cell Carcinoma

• EMA approval · 2026-06-03
  EMA Authorised: Ameluz (5-aminolevulinic acid hydrochloride) — Biofrontera Bioscience GmbH

  EMA authorised Ameluz (5-aminolevulinic acid hydrochloride) for actinic keratosis and basal cell carcinoma.

• EMA approval · 2026-02-20
  EMA Authorised: Ameluz (5-aminolevulinic acid hydrochloride) — Biofrontera Bioscience GmbH

  EMA authorized Ameluz (5-aminolevulinic acid hydrochloride) by Biofrontera Bioscience for actinic keratosis and basal cell carcinoma, markin…

• EMA approval · 2026-01-22
  EMA Authorised: Erivedge (vismodegib) — Roche Registration GmbH

  The European Medicines Agency authorised Erivedge (vismodegib) by Roche Registration GmbH for basal cell carcinoma.

• EMA approval · 2026-01-20
  EMA Authorised: Odomzo (sonidegib diphosphate) — Sun Pharmaceutical Industries Europe B.V.

  The European Medicines Agency has authorised Odomzo (sonidegib diphosphate) for basal cell carcinoma, with Sun Pharmaceutical Industries Eur…

• EMA approval · 2025-07-18
  EMA Authorised: Aldara (imiquimod) — Viatris Healthcare Limited

  The European Medicines Agency authorised Aldara (imiquimod) for multiple indications under Viatris Healthcare Limited, including genital war…

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• FDA approval · 2023-08-22
  FDA Approved: ODOMZO — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for ODOMZO (sonidegib) submitted by Sun Pharmaceutical Industries, Inc., resulting in changes to…

• FDA approval · 2020-07-31
  FDA Approved: ERIVEDGE — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for ERIVEDGE (vismodegib) from Genentech, Inc. to modify or expand its labeling for basal cell c…

• FDA approval · 2019-05-13
  FDA Approved: ODOMZO — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for ODOMZO (sonidegib) submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2017-09-18
  FDA Approved: ODOMZO — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for ODOMZO (sonidegib) by Sun Pharmaceutical Industries.

• FDA approval · 2017-08-01
  FDA Approved: ERIVEDGE — Supplemental Application (Genentech, Inc.)

  The FDA approved Genentech's supplemental application for ERIVEDGE (vismodegib). The action updates the product's labeling and indications f…

• FDA approval · 2016-11-02
  FDA Approved: ERIVEDGE — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for ERIVEDGE (vismodegib) filed by Genentech, Inc., expanding/ updating the drug's regulatory status…

• FDA approval · 2016-08-29
  FDA Approved: IMIQUIMOD — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Imiquimod submitted by Sun Pharmaceutical Industries. This action typically updates labeling…

• FDA approval · 2016-05-12
  FDA Approved: ODOMZO — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Sun Pharmaceutical's ODOMZO (sonidegib) submitted by Sun Pharmaceutical Industries, Inc.

• CLINICAL_TRIALS approval · 2015-08-06
  Clinical Trial Update: A Study of Vismodegib (GDC-0449) in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

  Vismodegib (GDC-0449) received marketing approval for use in locally advanced or metastatic basal cell carcinoma, per the clinical trial upd…

• FDA approval · 2015-07-24
  FDA Approved: ODOMZO — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved the original application for ODOMZO (sonidegib) by Sun Pharmaceutical Industries, Inc. for adults with basal cell carcinoma not…

• FDA approval · 2015-05-21
  FDA Approved: ERIVEDGE — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for Vismodegib (ERIVEDGE) filed by Genentech, Inc. The action expands the drug's labeling/indica…

• FDA approval · 2013-06-03
  FDA Approved: ERIVEDGE — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for Erivedge (vismodegib) submitted by Genentech, updating or expanding its label.

• FDA approval · 2013-05-08
  FDA Approved: ERIVEDGE — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for ERIVEDGE (vismodegib) by Genentech.

• FDA approval · 2012-01-30
  FDA Approved: ERIVEDGE — Original Application (Genentech, Inc.)

  The FDA approved Erivedge (vismodegib) in Genentech's original NDA for the treatment of advanced basal cell carcinoma.