Tafinlar Plus Mekinist Approved for Pediatric BRAF V600E Low-Grade Glioma
The FDA approved the combination to treat pediatric patients 1 year of age and older who have low-grade glioma with a BRAF V600E mutation and require systemic therapy.
The FDA approved the combination to treat pediatric patients 1 year of age and older who have low-grade glioma with a BRAF V600E mutation and require systemic therapy.
The FDA has authorized use of the bivalent Pfizer-BioNTech COVID-19 vaccine as a booster dose for children 6 months through 4 years of age.
An FDA panel voted in favor of approving polatuzumab vedotin in combination with R-CHP for previously untreated DLBCL.
Stimufend (pegfilgrastim-fpgk), a biosimilar to Neulasta (pegfilgrastim), has been made available by Fresenius Kabi.
Kepivance is expected to be available again in October 2023.
As a noncovalent inhibitor of BTK, pirtobrutinib is able to reestablish BTK inhibition in patients previously treated with covalent BTK inhibitors.
The approval was based on data from the KEYNOTE-091 trial.
Recent data showed that Evusheld is unlikely to be active against currently circulating SARS-CoV-2 variants.
The FDA and CDC are investigating whether the Pfizer-BioNTech bivalent COVID-19 vaccine increases the risk of ischemic stroke in older patients.
The FDA has approved Rezlidhia (olutasidenib) to treat patients with IDH1-mutated, relapsed or refractory acute myeloid leukemia.