Pancreatic Cancer

• EMA approval · 2026-03-19
  EMA Authorised: Lynparza (olaparib) — AstraZeneca AB

  The EMA authorised Lynparza (olaparib) for multiple cancers in the European Union. Indications include ovarian cancer, breast cancer, pancre…

• EMA approval · 2026-01-21
  EMA Authorised: Abraxane (paclitaxel) — Bristol-Myers Squibb Pharma EEIG

  EMA authorised Abraxane (paclitaxel) by Bristol-Myers Squibb Pharma EEIG for breast cancer, pancreatic cancer, and non-small cell lung cance…

• EMA approval · 2025-11-20
  EMA Authorised: Afinitor (everolimus) — Novartis Europharm Limited

  EMA authorised Afinitor (everolimus) for renal cell carcinoma, breast cancer and pancreatic neoplasms. The marketing authorisation holder is…

• FDA approval · 2025-11-12
  FDA Tentative Approval: FLUOROURACIL — Supplemental Application (Gland Pharma Limited)

  FDA Tentative Approval for Fluorouracil from Gland Pharma Limited under an ANDA, indicating a pathway to U.S. market subject to regulatory t…

• EMA approval · 2025-08-12
  EMA Authorised: Naveruclif (paclitaxel) — Accord Healthcare S.L.U.

  EMA authorised Naveruclif (paclitaxel) by Accord Healthcare S.L.U. for breast cancer, pancreatic cancer, and non-small cell lung cancer.

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• EMA approval · 2025-06-10
  EMA Authorised: Apexelsin (paclitaxel) — Whiteoak Pharmaceutical B.V.

  The EMA authorised Apexelsin (paclitaxel) for breast cancer, pancreatic cancer, and non-small cell lung cancer, with Whiteoak Pharmaceutical…

• FDA approval · 2025-05-15
  FDA Approved: PACLITAXEL PROTEIN-BOUND PARTICLES FOR INJECTABLE SUSPENSION (ALBUMIN-BOUND) — Original Application (BluePoint Laboratories)

  FDA approved the original application for paclitaxel protein-bound particles for injectable suspension (albumin-bound) from BluePoint Labora…

• EMA approval · 2025-03-05
  EMA Authorised: Tarceva (erlotinib) — Cheplapharm Registration GmbH

  Tarceva (erlotinib) has been authorised in the EU with Cheplapharm Registration GmbH as the marketing authorisation holder for non-small cel…

• CLINICAL_TRIALS approval · 2025-01-17
  Clinical Trial Update: Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation

  Eli Lilly's RET inhibitor selpercatinib (Retevmo) has been approved for marketing to treat cancers driven by RET activation, including non-s…

• FDA approval · 2024-09-24
  FDA Approved: GEMCITABINE HYDROCHLORIDE — Supplemental Application (Teyro Labs Private Limited)

  FDA approved a supplemental application for Gemcitabine hydrochloride from Teyro Labs Private Limited, authorizing continued approval of thi…

• FDA approval · 2024-05-24
  FDA Approved: ERLOTINIB — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' original application for Erlotinib (ERLOTINIB), enabling a generic version of the cancer drug to be…

• FDA approval · 2024-02-13
  FDA Approved: ONIVYDE — Supplemental Application (Ipsen Biopharmaceuticals, Inc.)

  The FDA approved a supplemental application for ONIVYDE (irinotecan hydrochloride) by Ipsen Biopharmaceuticals, Inc.

• 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 · 2023-05-31
  FDA Approved: LYNPARZA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for LYNPARZA (olaparib) from AstraZeneca Pharmaceuticals LP, resulting in changes to the product…

• FDA approval · 2023-03-07
  FDA Approved: GEMCITABINE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s generic gemcitabine under an Original Application (ANDA). This marks the approval of a generic…

• FDA approval · 2023-02-03
  FDA Approved: ONIVYDE — Supplemental Application (Ipsen Biopharmaceuticals, Inc.)

  The FDA approved a supplemental application for ONIVYDE (liposomal irinotecan), submitted by Ipsen Biopharmaceuticals, Inc.

• FDA approval · 2022-10-20
  FDA Approved: PACLITAXEL — Original Application (BluePoint Laboratories)

  FDA approves paclitaxel as a generic product under an original application from BluePoint Laboratories.

• FDA approval · 2022-10-18
  FDA Approved: FLUOROURACIL — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved a supplemental application for fluorouracil submitted by Taro Pharmaceuticals U.S.A., Inc., approving changes to the product’s …

• FDA approval · 2022-09-14
  FDA Approved: FLUOROURACIL — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for fluorouracil submitted by BluePoint Laboratories, indicating approval of an ANDA supplement. Thi…

• FDA approval · 2022-07-27
  FDA Approved: PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND — Original Application (American Regent, Inc.)

  FDA approved paclitaxel protein-bound particles albumin-bound (paclitaxel) from American Regent, Inc. under an Original Application (NDA2118…

• FDA approval · 2022-06-22
  FDA Approved: ERLOTINIB — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's original application for a generic erlotinib product. Erlotinib is used to treat certain cancers…

• FDA approval · 2021-07-08
  FDA Approved: ERLOTINIB HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's Erlotinib Hydrochloride original application (ANDA214719), authorizing a generic Erlotinib hy…

• FDA approval · 2021-05-10
  FDA Approved: ERLOTINIB HYDROCHLORIDE — Original Application (Novadoz Pharmaceuticals LLC)

  The FDA approved the original ANDA for erlotinib hydrochloride (generic) from Novadoz Pharmaceuticals LLC, making a generic version availabl…

• FDA approval · 2020-12-11
  FDA Approved: GEMCITABINE — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals' generic gemcitabine hydrochloride under an original ANDA.

• FDA approval · 2020-11-09
  FDA Approved: ERLOTINIB — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's original ANDA for erlotinib, providing a generic version of the cancer drug.