FDA News

FDA grants Humanitarian Device Exemption for OncoSil, the first Class III device delivering targeted P-32 microparticles for distal bile duct cancer.

Oncology clinical trial nurse navigator Elise Curry, RN, explains the impact of the FDA's approval of oral iberdomide for multiple myeloma.

The FDA granted accelerated approval to iberdomide with daratumumab and dexamethasone for relapsed/refractory multiple myeloma.

FDA approves Tudriqev-nivolumab for advanced melanoma. Learn key clinical trial data, dosing math, and safety rules for oncology nursing teams.

Dr. Michael Wong discusses clinical workflows, dosing calculations, and biosafety protocols for the newly approved Tudriqev-nivolumab regimen.

FDA approves Tudriqev with nivolumab for advanced cutaneous melanoma. Learn about dosing, safety warnings, and trial data for oncology nurses.

FDA approves Pluvicto with ARPI for PSMA-positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer based on rPFS data.

Handa Oncology received FDA tentative approval for Omcazio capsules, a novel cabozantinib formulation with improved absorption and no food effects.

Sunny Pharmtech recalls three lots of Cyclophosphamide for Injection after steel particulates were found, posing risks of thromboembolic events.

The FDA approved zidesamtinib for metastatic ROS1-positive NSCLC following prior kinase inhibitor therapy, offering hope for patients with resistance.

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 Azurity’s Aprepitant Injectable Emulsion, a polysorbate-80-free, ready-to-use IV option for preventing chemotherapy-induced nausea.

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.