FDA News

FDA approves tucatinib maintenance with trastuzumab and pertuzumab for HER2+ breast cancer based on HER2CLIMB-05.

FDA approves pirtobrutinib for untreated CLL/SLL without 17p deletion based on BRUIN CLL-313 data. Read key nursing safety takeaways.

An FDA advisory panel voted to approve GRAIL's Galleri multi-cancer early detection test for adults 50+. Read key oncology nursing takeaways.

FDA approves belzutifan with lenvatinib for advanced clear cell RCC after PD-1/PD-L1 inhibitor failure. Review LITESPARK-011 data and nursing takeaways.

FDA approves lirafugratinib (Lyrfigtu) for FGFR2+ cholangiocarcinoma. Review REFOCUS trial data, 70 mg daily dosing, and nursing safety guidelines.

FDA approves lutetium lu 177 dotatate (Bravnetsa) as bioequivalent to Lutathera for GEP-NETs. Review key nursing takeaways and safety guidelines.

FDA approves imlunestrant plus abemaciclib for ESR1-mutated, ER-positive, HER2-negative advanced or metastatic breast cancer after endocrine therapy.

FDA approves sNDA for taletrectinib (Ibtrozi) in ROS1+ NSCLC with updated DOR of nearly 50 months.

The FDA expands accelerated approval for sevabertinib to frontline HER2-mutant NSCLC, highlighting a need for vigilant nursing management of diarrhea.

The FDA expands accelerated approval for sevabertinib to frontline HER2-mutant NSCLC, highlighting a need for vigilant nursing management of diarrhea.

FDA grants accelerated approval to sevabertinib (Hyrnuo) for HER2 TKD-mutant non-squamous NSCLC, expanding access to treatment-naive patients.

FDA approves camizestrant for ESR1-mutated advanced breast cancer, tasking oncology nurses with guiding patients through ctDNA-based surveillance.

FDA grants accelerated approval to camizestrant with a CDK4/6 inhibitor for adult patients with ESR1-mutated HR+/HER2- advanced breast cancer.

Oncology nursing guide to the FDA approval of zanidatamab-hrii for HER2+ gastroesophageal cancers, featuring insights from Joe Chichioco, RN, MPH.

Experts share critical clinical protocols for managing daraxonrasib (Rasonque) following its landmark FDA approval.

FDA approves rusfertide (Mimrylo), a first-in-class hepcidin mimetic that regulates iron to control erythrocytosis in patients with polycythemia vera.

FDA approves BESREMi (ropeginterferon alfa-2b-njft) as the first new treatment option for essential thrombocythemia in nearly three decades.

Surbhi Sidana, MD, discusses how the FDA-approved oral CELMoD iberdomide expands access and impacts nursing care in multiple myeloma.

The FDA has approved daraxonrasib for metastatic pancreatic cancer. MSK's Mary Larsen, MSN, RN, OCN, shares essential nursing protocols for care.

FDA approves daraxonrasib, a first-in-class daily oral RAS inhibitor, doubling survival in metastatic pancreatic adenocarcinoma patients.

FDA approves two Ziihera combinations as a first-line treatment standard for adults with HER2-positive advanced gastroesophageal adenocarcinoma.

Oncology clinical trial nurse navigator Elise Curry, RN, breaks down the key clinical questions surrounding the FDA approval of oral iberdomide.

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.