Immune-Onc Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the development of innovative therapies in immunology and oncology, has achieved a significant milestone with the U.S. Food and Drug Administration’s (FDA) recent Orphan Drug Designation for IO-202. This designation is a crucial step forward in the treatment of chronic myelomonocytic leukemia (CMML), a rare form […]
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 […]
Eli Lilly’s oncology arm, Loxo@Lilly, disclosed that The New England Journal of Medicine (NEJM) has published an extensive analysis of results from the BRUIN Phase 1/2 trials on pirtobrutinib, a reversible Bruton’s tyrosine kinase (BTK) inhibitor. Pirtobrutinib is being investigated for use in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who […]
Aurobindo Pharma, along with its subsidiary Eugia Pharma Specialities has announced a voluntary sub-licensing agreement with Medicines Patent Pool (MPP) to develop and market Nilotinib Capsules. Originally developed by Novartis, Nilotinib Capsules are used for the treatment of chronic myeloid leukemia (CML) in 44 low and middle-income countries (LMIC). This agreement covers seven countries where […]
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 […]
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 […]
Rigel Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its Rezlidhia (olutasidenib) capsules for relapsed or refractory (R/R) acute myeloid leukemia (AML) in adult patients. Rezlidhia is indicated for patients with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as identified by an FDA-approved test. The oral, small molecule and mutant isocitrate […]
Alembic Pharmaceuticals has secured tentative approval for the abbreviated new drug application (ANDA) of Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg from the US Food and Drug Administration (FDA). The tentatively approved product is the generic of Bristol Myers Squibb Company’s Sprycel Tablets, 20 mg, 50 mg, […]
Aurobindo Pharma said that its subsidiary Eugia Pharma Specialities has secured approval from the US Food and Drug Administration (FDA) for the new drug application for its Cyclophosphamide Injection 500 mg/2.5 mL and 1 g/5 mL vials. Cyclophosphamide Injection is indicated in the US for malignant lymphomas, multiple myeloma, neuroblastoma, adenocarcinoma of the ovary, retinoblastoma, […]
Rylaze FDA approval : Jazz Pharmaceuticals has secured approval for its leukemia drug Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn or JZP458) from the US Food and Drug Administration (FDA). The Irish biopharma company bagged the approval for the drug to be used as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic […]