Head and Neck Squamous Cell Carcinoma

• EMA approval · 2026-02-12
  EMA Authorised: Foscan (temoporfin) — Biolitec Pharma Ltd

  The European Medicines Agency authorised Foscan (temoporfin) for head and neck squamous cell carcinoma, with Biolitec Pharma Ltd as the mark…

• FDA approval · 2024-05-10
  FDA Approved: CISPLATIN — Original Application (Apotex Corp.)

  FDA approved the original application for cisplatin from Apotex Corp., enabling the generic version to be marketed in the United States.

• FDA approval · 2023-09-19
  FDA Approved: DOCETAXEL — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal's supplemental application to manufacture and market a generic docetaxel, enabling its supply for cancer treatment i…

• FDA approval · 2022-11-22
  FDA Approved: DOCIVYX — Original Application (Avyxa Pharma, LLC)

  FDA approves DOCIVYX (docetaxel) under an original NDA submitted by Avyxa Pharma, LLC.

• FDA approval · 2021-10-25
  FDA Approved: METHOTREXATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves a supplemental application for Methotrexate by Hikma Pharmaceuticals USA Inc., enabling a new generic version of the drug.

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• FDA approval · 2021-09-24
  FDA Approved: ERBITUX — Supplemental Application (ImClone LLC)

  The FDA approved a supplemental application for Erbitux (cetuximab) submitted by ImClone LLC.

• FDA approval · 2021-07-01
  FDA Approved: DOCETAXEL — Original Application (Gland Pharma Limited)

  FDA approves Gland Pharma Limited's generic docetaxel as an Original Application, adding a new generic option for cancer chemotherapy.

• FDA approval · 2020-03-05
  FDA Approved: CARBOPLATIN — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application for carboplatin filed by Apotex Corp., authorizing changes to an approved generic product.

• FDA approval · 2018-03-15
  FDA Approved: METHOTREXATE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Methotrexate submitted by Hospira, Inc.

• FDA approval · 2017-08-09
  FDA Approved: DOCETAXEL — Original Application (Jiangsu Hengrui Pharmaceuticals Co., Ltd.)

  FDA approved a generic version of docetaxel under an original ANDA from Jiangsu Hengrui Pharmaceuticals Co., Ltd., enabling market authoriza…

• FDA approval · 2016-08-23
  FDA Approved: PACLITAXEL PACLITAXEL — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved the original application for a generic paclitaxel product, manufactured by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmac…

• FDA approval · 2015-04-10
  FDA Approved: ERBITUX — Supplemental Application (ImClone LLC)

  The FDA approved a supplemental application for ERBITUX (cetuximab) submitted by ImClone LLC. This action pertains to a supplemental approva…

• FDA approval · 2014-05-15
  FDA Approved: DOCETAXEL — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for Docetaxel (Sanofi-Aventis U.S. LLC), indicating an approved modification to its labeling and…

• FDA approval · 2012-03-15
  FDA Approved: CISPLATIN — Supplemental Application (Teva Parenteral Medicines, Inc.)

  FDA approved a supplemental application for cisplatin from Teva Parenteral Medicines, Inc., marking an approved change to the drug's regulat…

• FDA approval · 2011-11-07
  FDA Approved: ERBITUX — Supplemental Application (ImClone LLC)

  The FDA approved a supplemental application for ERBITUX (cetuximab) submitted by ImClone LLC.

• FDA approval · 2011-03-24
  FDA Approved: ERBITUX — Supplemental Application (ImClone LLC)

  FDA approved a supplemental application for Erbitux (cetuximab) from ImClone LLC, updating or expanding its labeling.

• FDA approval · 2008-01-28
  FDA Approved: BLEOMYCIN — Original Application (Fresenius Kabi USA, LLC)

  The FDA approved Fresenius Kabi USA's original ANDA for bleomycin sulfate, making a generic version of bleomycin available. Bleomycin is an …