Natco Pharma Limited said that its marketing partner – Breckenridge Pharmaceutical Inc. (BPI), has secured approval from the US Food and Drug Administration (FSA) for its abbreviated new drug application (ANDA) for Carfilzomib Vials ANDA (generic for KYPROLIS). Developed by Onyx Pharmaceuticals, KYPROLIS (carfilzomib) is indicated in the US for the treatment of multiple myeloma […]
Natco Pharma has secured the final approval from the US Food and Drug Administration (FDA) of its abbreviated new drug application (ANDA) for Lenalidomide Capsules, 5mg, 1 Omg, 15mg, and 25mg, and the tentative approval of the 2.5mg and 20mg. Lenalidomide Capsules is the generic for Bristol-Myers Squibb’s REVLIMID, which is indicated in the US […]
Abecma FDA approval : Bristol Myers Squibb (BMS) and bluebird bio have secured approval from the US Food and Drug Administration (FDA) for Abecma (idecabtagene vicleucel; ide-cel) for the treatment of relapsed or refractory multiple myeloma. The approval is for Abecma’s use in the treatment of relapsed or refractory multiple myeloma in adult patients following […]
Takeda Pharmaceutical said that the Phase 3 TOURMALINE-MM2 trial in newly diagnosed multiple myeloma patients for NINLARO (ixazomib) in addition to lenalidomide and dexamethasone failed to meet the primary endpoint of progression-free survival (PFS). The late-stage trial assessed the combination of NINLARO (ixazomib) with lenalidomide and dexamethasone in comparison to lenalidomide and dexamethasone plus placebo […]
DKd regiment FDA approval for multiple myeloma : Janssen Pharmaceutical Companies of Johnson & Johnson and Amgen have been granted an expanded approval from the US Food and Drug Administration (FDA) for the DKd regimen comprising the former’s DARZALEX (daratumumab) and the latter’s Kyprolis (carfilzomib) plus dexamethasone for the treatment of multiple myeloma. The approval […]
Cellectis said that it has dosed the first patient in a phase 1 study – the MELANI-01 clinical trial to evaluate UCARTCS1, an allogeneic off-the-shelf CAR-T product candidate for the treatment of relapsed/refractory multiple myeloma (R/R MM). The French gene therapy company began the phase 1 dose-escalation study after getting clearance from the US Food […]
CANDOR clinical trial results : Amgen said that a phase 3 study assessing Kyprolis (carfilzomib) in combination with dexamethasone and Johnson & Johnson’s Darzalex (daratumumab) (KdD) compared to Kyprolis and dexamethasone alone (Kd), called CANDOR, met its primary endpoint of progression-free survival (PFS) in multiple myeloma patients. The Amgen clinical trial featured 466 relapsed or […]
The United States Food and Drug Administration (FDA) has granted approval for a new once-weekly dosing regimen of Amgen’s Kyprolis (carfilzomib) in combination with dexamethasone for patients with relapsed or refractory multiple myeloma. This new regimen, known as the once-weekly Kd70, involves administering Kyprolis at a dose of 70 mg/m². The approval follows the results […]
Janssen Pharmaceutical Companies of Johnson & Johnson encountered a significant setback with their esketamine nasal spray in a phase 3 trial aimed at treating patients with treatment-resistant depression. The trial’s results revealed that esketamine did not meet its primary endpoint, sparking concern among industry experts and stakeholders. The late-stage study assessed the efficacy of two […]
The Janssen Pharmaceutical Companies of Johnson & Johnson have achieved a significant milestone with the European Commission’s approval of Darzalex (daratumumab) for use as an initial therapy in adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). This approval allows for the combination of daratumumab with bortezomib, […]