FDA Approvals, News & Updates
On November 20, 2024, officials with the FDA granted accelerated approval to zanidatamab-hrii (Ziihera; Jazz Pharmaceuticals, Inc), a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive biliary tract cancer, as detected by an FDA-approved test. Read More ›
On November 19, 2024, the FDA approved updated drug labeling for fludarabine phosphate (Fludarabine Phosphate Injection; Sandoz) under Project Renewal, a public health initiative under the Oncology Center of Excellence program, which is designed to update labeling information for certain older oncology drugs to ensure information is clinically meaningful. Read More ›
On December 13, 2024, FDA officials approved cosibelimab-ipdl (Unloxcyt; Checkpoint Therapeutics, Inc), a programmed death ligand-1 (PD-L1)-blocking antibody, for adults with locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation or metastatic cutaneous squamous cell carcinoma. Read More ›
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 ›