FDA News
The FDA has approved the expanded use of elexacaftor/tezacaftor/ivacaftor and ivacaftor (Trikafta; Vertex) for the treatment of people with cystic fibrosis (CF) ≥2 who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation that is responsive to the treatment based on clinical and/or in vitro data. Read More ›
Officials with the FDA issued Zealand Pharma a response letter saying that the application did not meet the full requirements for substantial evidence to establish the efficacy and safety of the to-be-marketed dose of glepaglutide for the treatment of short bowel syndrome in adults with intestinal failure. Read More ›
Officials with the FDA have approved durvalumab (Imfinzi; AstraZeneca) for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Read More ›
Zenocutuzumab-zbco (Bizengri; Merus N.V.) has been granted accelerated approval for adults with advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy or advanced, unresectable, or metastatic non–small cell lung cancer (NSCLC) harboring an NRG1 gene fusion with disease progression on or after prior systemic therapy. Read More ›
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 (IHC 3+) biliary tract cancer (BTC), 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 (mCSCC). Read More ›
Shield, Guardant Health has been FDA approved and is now covered by Medicare as the first blood test for primary colorectal cancer (CRC) screening. Read More ›
On June 26, 2024, the FDA approved epcoritamab-bysp (Epkinly; Abbvie and Genmab) as the first and only T-cell engaging bispecific antibody administered subcutaneously for the treatment of adults with relapsed or refractory follicular lymphoma (FL) after ≥2 lines of prior therapy. Read More ›