Mantle Cell Lymphoma
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-03-12EMA Authorised: Tecartus (autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel)) — Kite Pharma EU B.V.
The European Medicines Agency authorised Tecartus (brexucabtagene autoleucel) for mantle cell lymphoma with conditional approval, and it has…
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EMA approval · 2026-03-12EMA Authorised: Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto) (lenalidomide hydrochloride monohydrate) — Krka, d.d., Novo mesto
EMA authorised Lenalidomide Krka (lenalidomide hydrochloride monohydrate) for several hematologic malignancies, including multiple myeloma, …
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FDA approval · 2026-02-19FDA Approved: CALQUENCE — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA approves a supplemental application for CALQUENCE (acalabrutinib) submitted by AstraZeneca Pharmaceuticals LP.
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EMA approval · 2026-02-17EMA Authorised: Imbruvica (Ibrutinib) — Janssen-Cilag International NV
EMA authorised Imbruvica (ibrutinib) for mantle cell lymphoma and chronic lymphocytic leukemia, with Janssen-Cilag International NV as the m…
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EMA approval · 2026-01-28EMA Authorised: Jaypirca (pirtobrutinib) — Eli Lilly Nederland B.V.
The European Medicines Agency authorised Jaypirca (pirtobrutinib) for mantle cell lymphoma under conditional approval.
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FDA approval · 2026-01-06FDA Approved: BORTEZOMIB — Original Application (Gland Pharma Limited)
FDA approved the original application for Bortezomib from Gland Pharma Limited as a generic injectable, covering indications established for…
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FDA approval · 2025-10-21FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)
FDA approved a supplemental application for IMBRUVICA (ibrutinib) submitted by Pharmacyclics LLC.
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EMA approval · 2025-09-09EMA Authorised: Revlimid (lenalidomide) — Bristol-Myers Squibb Pharma EEIG
The European Medicines Agency authorised Revlimid (lenalidomide) for multiple indications including multiple myeloma, mantle cell lymphoma, …
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FDA approval · 2025-06-10FDA Approved: BRUKINSA — Original Application (BeOne Medicines USA, Inc.)
The FDA approved the original application for Brukinsa (zanubrutinib) from BeOne Medicines USA, Inc., marking the U.S. approval of this BTK …
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FDA approval · 2025-05-22FDA Approved: LENALIDOMIDE — Original Application (Devatis Inc.)
FDA approved a generic lenalidomide under the original application from Devatis Inc., enabling market access for this established cancer the…
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EMA approval · 2025-03-03EMA Authorised: Torisel (temsirolimus) — Pfizer Europe MA EEIG
EMA authorised temsirolimus (Torisel) for renal cell carcinoma and mantle cell lymphoma in the EU, with Pfizer Europe MA EEIG as the marketi…
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FDA approval · 2025-03-03FDA Approved: LENALIDOMIDE — Original Application (BIOCON PHARMA INC.,)
FDA approved Biocon Pharma Inc.'s lenalidomide as an original ANDA, enabling a generic version of the cancer drug. Indications include multi…
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CLINICAL_TRIALS approval · 2025-02-03Clinical Trial Update: An Open Label Treatment Use Protocol for Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
The document reports marketing approval of ibrutinib for relapsed or refractory mantle cell lymphoma.
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FDA approval · 2025-01-31FDA Approved: LENALIDOMIDE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved Amneal Pharmaceuticals NY LLC's generic lenalidomide (LENALIDOMIDE) under an Original Application (ANDA 216213).
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CLINICAL_TRIALS approval · 2024-12-18Clinical 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…
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FDA approval · 2024-09-11FDA Approved: LENALIDOMIDE — Original Application (Novugen Pharma (USA) LLC)
FDA approved the original application for lenalidomide from Novugen Pharma (USA) LLC, enabling a generic version of the cancer drug lenalido…
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FDA approval · 2024-08-26FDA Approved: BORUZU — Original Application (Amneal Pharmaceuticals LLC)
FDA approved BORUZU (bortezomib) from Amneal Pharmaceuticals as an original NDA. The approval covers indications including multiple myeloma …
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FDA approval · 2024-05-03FDA Approved: BORTEZOMIB — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' generic Bortezomib through an Original Application (ANDA 212204). This approval makes a generic version…
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FDA approval · 2024-02-26FDA Approved: BENDAMUSTINE HYDROCHLORIDE — Supplemental Application (Baxter Healthcare Corporation)
FDA approved a supplemental application for bendamustine hydrochloride (Baxter Healthcare Corporation) under NDA 216078.
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FDA approval · 2024-02-22FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)
The FDA approved a supplemental application for IMBRUVICA (ibrutinib) submitted by Pharmacyclics LLC.
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FDA approval · 2024-02-08FDA Approved: VIVIMUSTA — Supplemental Application (Azurity Pharmaceuticals, Inc.)
The FDA approved a supplemental application for VIVIMUSTA (bendamustine hydrochloride) filed by Azurity Pharmaceuticals, Inc., to update/exp…
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FDA approval · 2024-01-11FDA Approved: BELRAPZO — Supplemental Application (Eagle Pharmaceuticals, Inc)
The FDA approved a supplemental application for Belrapzo (bendamustine hydrochloride) submitted by Eagle Pharmaceuticals, Inc. The action up…
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FDA approval · 2023-10-05FDA Approved: LENALIDOMIDE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for lenalidomide submitted by Zydus Pharmaceuticals USA Inc. under ANDA210154, updating the lena…
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FDA approval · 2023-06-05FDA Approved: BENDAMUSTINE — Original Application (Meitheal Pharmaceuticals Inc.)
The FDA approved the original application for Bendamustine HCl from Meitheal Pharmaceuticals Inc., sanctioning a generic version of bendamus…
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FDA approval · 2023-03-24FDA Approved: LENALIDOMIDE — Supplemental Application (Apotex Corp.)
FDA approved Apotex Corp.'s supplemental application for lenalidomide (ANDA211022), authorizing the marketing of a generic lenalidomide prod…