FDA Approvals, News & Updates

A regular column that features the 2024 approvals and updates from the Food and Drug Administration. Read More ›

Officials with the FDA recently approved the menin inhibitor revumenib (Revuforj; Syndax Pharmaceuticals, Inc.) for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene translocation. Read More ›

The CD19-directed genetically modified autologous T-cell immunotherapy, obecabtagene autoleucel (Aucatazyl; Autolus Inc.), has been approved for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Read More ›

Asciminib (Scemblix; Novartis AG) has been approved for use in adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Read More ›

Officials with the Food and Drug Administration have approved zolbetuximab-clzb (Vyloy, Astellas Pharma US, Inc.) Read More ›

Officials with the FDA have approved inavolisib (Itovebi, Genentech, Inc.) with palbociclib (Ibrance) and fulvestrant (Faslodex) for adults with endocrine-resistant,... Read More ›

Officials with the FDA have approved nivolumab (Opdivo, Bristol Myers Squibb Company) with platinum-doublet chemotherapy as neoadjuvant treatment,... Read More ›

Selpercatinib (Retevmo, Eli Lilly and Company) is now available for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer with a RET mutation,... Read More ›

Osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) has received another new indication,... Read More ›

Officials with the FDA have approved isatuximab-irfc (Sarclisa, Sanofi-Aventis U.S. LLC) with bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone for adults... Read More ›