FDA granted accelerated approval to Iclusig (ponatinib) with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
FDA has approved safety labeling changes for fluorouracil injection products. This effort was a collaboration between FDA’s Office of Generic Drugs and the Oncology Center of Excellence.
The Jackson Laboratory, LG AI Research partner to use AI to diagnose and treat cancer, Alzheimer’s
The Jackson Laboratory (JAX) and LG AI Research signed a partnership agreement creating an alliance between JAX’s expertise in biomedical research and data analysis and LG AI Research’s AI technology and product development experience.
Tempus has sent de-identified tumor profiles with limited associated clinical information from more than 3,000 cancer diagnoses to the NCI.Â
FDA has granted accelerated approval of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor CAR T-cell therapy for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. Â
FDA has approved Tevimbra (tislelizumab-jsgr) as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.Â
FDA approved Rybrevant (amivantamab-vmjw) with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor, or EGFR, exon 20 insertion mutations, as detected by an FDA-approved test.
FDA approved Opdivo (nivolumab) in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
FDA granted accelerated approval to Brukinsa (zanubrutinib) with obinutuzumab for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
FDA approved Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), the first FDA-approved denosumab biosimilars, to treat all indications of the reference medicines.
