Waldenström Macroglobulinemia

• EMA approval · 2025-11-24
  EMA Authorised: Brukinsa (zanubrutinib) — BeOne Medicines Ireland Limited

  The European Medicines Agency authorised Brukinsa (zanubrutinib) for Waldenström macroglobulinemia, with BeOne Medicines Ireland Limited as …

• FDA approval · 2025-10-21
  FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)

  FDA approved a supplemental application for IMBRUVICA (ibrutinib) submitted by Pharmacyclics LLC.

• CLINICAL_TRIALS approval · 2024-12-18
  Clinical Trial Update: Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer

  The document notes that pirtobrutinib is approved for marketing in relation to an expanded access program for multiple B-cell cancers, cover…

• FDA approval · 2024-02-22
  FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)

  The FDA approved a supplemental application for IMBRUVICA (ibrutinib) submitted by Pharmacyclics LLC.

• FDA approval · 2023-01-19
  FDA Approved: BRUKINSA — Supplemental Application (BeOne Medicines USA, Inc.)

  FDA approved a supplemental application for BRUKINSA (zanubrutinib) submitted by BeOne Medicines USA, Inc.

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• FDA approval · 2022-08-24
  FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)

  The FDA approved a supplemental application for IMBRUVICA (ibrutinib) submitted by Pharmacyclics LLC.

• FDA approval · 2022-05-11
  FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)

  FDA approved a supplemental application for IMBRUVICA (ibrutinib) from Pharmacyclics LLC.

• FDA approval · 2022-05-11
  FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)

  FDA approves a supplemental application for IMBRUVICA (ibrutinib) submitted by Pharmacyclics LLC. The document indicates FDA approval of the…

• FDA approval · 2020-12-17
  FDA Approved: RIABNI — Original Application (Amgen, Inc)

  FDA approved RIABNI (rituximab-arrx) from Amgen as a biosimilar to rituximab via Original Application.

• FDA approval · 2020-08-07
  FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)

  FDA approved a supplemental application for IMBRUVICA (ibrutinib) submitted by Pharmacyclics LLC.

• FDA approval · 2020-04-21
  FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)

  FDA approved a supplemental application for IMBRUVICA (ibrutinib) submitted by Pharmacyclics LLC.

• FDA approval · 2019-05-23
  FDA Approved: TRUXIMA — Supplemental Application (Cephalon, Inc.)

  FDA approved a supplemental application for TRUXIMA (rituximab-ABBS) submitted by Cephalon, Inc.

• FDA approval · 2016-03-21
  FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)

  FDA approved a supplemental application for IMBRUVICA (ibrutinib) filed by Pharmacyclics LLC. The document indicates FDA action on a supplem…