FDA News

NATCO Pharma receives tentative U.S. FDA approval for a generic version of the PARP inhibitor olaparib (Lynparza) for oncology indications.

FDA approves gedatolisib for HR+/HER2– breast cancer. Learn about the VIKTORIA-1 trial, dosing, and nursing strategies for managing stomatitis.

FDA approves gedatolisib with fulvestrant for adults with HR+/HER2- metastatic breast cancer following endocrine therapy progression.

The FDA has granted traditional approval to selpercatinib for adult and pediatric patients with RET fusion-positive solid tumors post-progression.

FDA approves SC isatuximab-irfc with the CirCLIQ on-body injector, streamlining multiple myeloma care and reducing nursing burden.

FDA expanded pembrolizumab and enfortumab vedotin-ejfv for all surgery-eligible adults with muscle-invasive bladder cancer following positive trial data.

FDA approves subcutaneous isatuximab-irfc for multiple myeloma indications, offering an efficient delivery alternative to intravenous administration.

FDA approves Ennumo (pegfilgrastim-pccg), a biosimilar to Neulasta, providing a new option for oncology nurses to manage chemotherapy-induced neutropenia.

The FDA approved Tregzi, a precision-engineered cell therapy, to improve chronic GVHD-free survival in adults undergoing allogeneic transplant.

The FDA approved the BESREMi Pen for polycythemia vera, offering a simplified self-administration option to improve patient adherence and care.

FDA approves sacituzumab govitecan-hziy as monotherapy and with pembrolizumab for first-line treatment of advanced triple-negative breast cancer.

The FDA approved palbociclib (Ibrance) for maintenance in HR+/HER2+ metastatic breast cancer after induction therapy, based on the PATINA trial.

FDA approves capivasertib with abiraterone for PTEN-deficient mAPMN/S prostate cancer, requiring specific nursing education on intermittent dosing.

FDA approved belzutifan plus pembrolizumab for adjuvant clear cell renal cell carcinoma at high risk of recurrence following nephrectomy.

The FDA approved Cavhanza, a nilotinib ODT that allows co-administration with PPIs and H2RAs, easing dosing and administration for Ph+ CML patients.

The FDA approved durvalumab plus BCG for high-risk NMIBC based on significant disease-free survival gains in the POTOMAC trial.

FDA approves pivekimab sunirine-pvzy for adults with BPDCN, offering a new CD123-directed therapy for this ultra-rare hematologic malignancy.

FDA approves datopotamab deruxtecan-dlnk for first-line metastatic TNBC, improving PFS, OS and response rates vs chemotherapy.

The FDA approved T-DXd for neoadjuvant and adjuvant treatment of HER2-positive early breast cancer, showing improved pCR and IDFS rates.

FDA approves atezolizumab and a companion diagnostic for adjuvant treatment of MIBC in patients with detected circulating tumor DNA after surgery.

The FDA approved oral decitabine/cedazuridine and venetoclax for AML. Research showed a 41.6% complete remission rate in chemo-ineligible adults

The FDA approved sonrotoclax for R/R mantle cell lymphoma. Nurses must manage a 4-week dose ramp-up to prevent TLS for patients after prior BTK therapy.

Learn about the FDA approval of vepdegestrant (Veppanu), the first PROTAC for ESR1-mutated breast cancer, including nursing priorities and side effects.

FDA approved zenocutuzumab-zbco for post-systemic-therapy, NRG1 fusion–positive unresectable/metastatic cholangiocarcinoma, addressing an ultra-rare molecular subset with limited options.

FDA approved Veppanu for ER+, HER2- ESR1-mutated breast cancer after endocrine therapy, improving PFS to 5 months vs 2.1 and reducing progression risk by 43%.

FDA approves vepdegestrant for ER-positive, HER2-negative breast cancer. Learn key efficacy data, safety risks, and nursing care considerations.

FDA accepts Zanidatamab combo sBLA for HER2+ gastroesophageal cancer, showing improved outcomes in HERIZON-GEA-01 trial with priority review underway.

FDA grants Priority Review to enfortumab vedotin plus pembrolizumab in MIBC, showing improved survival and reduced recurrence risk in phase 3 EV-304 trial.