Zydus Lifesciences Limited, a leading pharmaceutical company, has achieved a significant milestone by receiving final approval from the United States Food and Drug Administration (USFDA) for its Cyclophosphamide Capsules USP, available in 25 mg and 50 mg dosages. This approval represents a major advancement in the field of oncology, as Cyclophosphamide is a key chemotherapy […]
Lantern Pharma Inc. (NASDAQ: LTRN), a trailblazer in artificial intelligence (AI) and machine learning (ML) for targeted cancer therapies, has received clearance from the United States Food and Drug Administration (FDA) for its investigational new drug (IND) application concerning LP-284. The cutting-edge drug is being developed for relapsed or refractory non-Hodgkin’s lymphoma (NHL), including mantle […]
Hanx Biopharmaceuticals (HanxBio) has obtained approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) of HX009, enabling the company to initiate a clinical trial in patients with relapsed/refractory lymphoma. HX009, developed by the Chinese biopharmaceutical company, is a bispecific antibody (BsAb) that targets both CD47 and PD-1 proteins. The […]
Danish biotech company Genmab has secured accelerated approval for EPKINLY (epcoritamab-bysp) from the US Food and Drug Administration (FDA) for the treatment of relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adults. The T-cell engaging bispecific antibody is indicated for diffuse large B-cell lymphoma resulting from indolent lymphoma, and high-grade B‑cell lymphoma, following […]
Glenmark Pharmaceuticals, through its subsidiary Glenmark Specialty, is set to begin a first-in-human, phase 1/2 clinical study of GRC 54276 in the US for the treatment of advanced solid tumors and lymphomas. This was after Glenmark Specialty’s investigational new drug (IND) application for GRC 54276 was accepted by the US Food and Drug Administration (FDA). […]
Loxo@Lilly, the oncology division of Eli Lilly and Company (Lilly), has secured the accelerated approval of the US Food and Drug Administration (FDA) for Jaypirca (pirtobrutinib) for the treatment of mantle cell lymphoma (MCL). To be available in 100mg and 50mg tablets, Jaypirca is specifically indicated for the treatment of adult patients having relapsed or […]
BeiGene has secured the approval of the US Food and Drug Administration (FDA) for the company’s Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Brukinsa FDA approval is backed by the findings of two global phase 3 clinical trials wherein Brukinsa showed superior efficacy and […]
Kite Pharma, a subsidiary of Gilead Sciences, and Daiichi Sankyo have received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for their Yescarta (axicabtagene ciloleucel) for initial treatment of relapsed/refractory large B-cell lymphoma (LBCL). Yescarta, a chimeric antigen receptor (CAR) T-cell therapy, is used only in patients who have not received a […]
Lunsumio FDA approval : Genentech, a subsidiary of the Roche Group, has secured the approval of the US Food and Drug Administration (FDA) for Lunsumio (mosunetuzumab-axgb) for the treatment of relapsed or refractory (R/R) follicular lymphoma (FL) in adults, subjected to two or more treatments for their cancer. Lunsumio is a CD20xCD3 T-cell engaging bispecific […]
Prescient Therapeutics has secured the orphan drug designation for its PTX-100 compound from the US Food and Drug Administration (FDA) for the treatment of peripheral T-cell lymphomas (PTCL). According to the Australian oncology company, the FDA orphan drug designation will enable it in getting incentives that can help the development of PTX-100, which is a […]