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NDA Filed for Zipalertinib in Lung Cancer
Cullinan Therapeutics says its partner, Taiho Oncology, has filed an NDA for zipalertinib in combination with platinum-based chemotherapy for treating patients with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations. he submission was made
FDA Oncology Chief Details Staffing, Clinical Trial Modernization Efforts
FDA Oncology Center of Excellence director Angelo De Claro says the center has retained its core regulatory experts despite staffing reductions across the agency and is pursuing new collaborations with the Department of Veterans Affairs and National Cancer Institute to modernize oncology clinical trials. Speaking during an 11/10 fireside
AdvaMed on Digital Breast Tomosynthesis Reclassification
AdvaMed says it is not taking a position on an FDA proposal to reclassify digital breast tomosynthesis systems from Class 3 into Class 2, but does have implementation concerns if the reclassification is approved. In its comment letter, the trade group says, “If FDA finalizes the proposed order, a clear,
FDA Posts 20 Form 483 Inspection Records
FDA has posted 20 Form 483 inspection records (see below), including reports involving sterile drug manufacturer Huons in South Korea, Bora Pharmaceutical Laboratories in Taiwan, Genzyme Ireland, Similasan in Switzerland, and medical device manufacturers in the U.S. and overseas. Their availability is part of the agency’s expanded transparency