The U.S. Food and Drug Administration placed a partial clinical hold on the TakeAim lymphoma study while the biotech company Curis provides further data to better understand safety and efficacy questions.
Gilead Combo Therapy Hit with FDA Hold Over Serious Adverse Events
Acute Myeloid Leukemia (AML), CD47 Protein, Clinical Trials, Combination Therapies, Diffuse large B-cell lymphoma (DLBCL), FDA/Regulatory, Gilead, Head & Neck Squamous Cell Carcinoma (HNSCC), Malignancies, Myelodysplastic Syndromes, Partial Clinical Hold, R&D, Triple Negative Breast Cancer (TNBC)The U.S. Food and Drug Administration placed a partial clinical hold on studies conducted by Gilead Sciences assessing the combination of magrolimab plus azacitidine due to concerns of unexpected serious adverse events between study arms.
China welcomed the first CAR T-cell therapy in the country following approval from the National Medical Products Administration.
FDA Action Alert: Bristol Myers Squibb/Juno, Seattle Genetics, BioMarin and Tricida
Adeno-Associated Virus (AAV), B Cell Lymphomas, Biologics License Application (BLA), Brain Metastases, CAR-T Therapy, Chronic Kidney Disease, Diffuse large B-cell lymphoma (DLBCL), FDA, FDA/Regulatory, Hemophilia A, HER2-positive breast cancer, Immunotherapy, New Drug Applicationa, Project Orbis, Quarterly results, T-CellsThe U.S. Food and Drug Administration’s approval-review schedule for August includes the Biologics License Application for Bristol Myers Squibb and Juno Therapeutics’ lisocabtagene maraleucel (liso-cel) for relapsed or refractory large B-cell lymphoma after at least two previous therapies.