In August 2024, the U.S. Food and Drug Administration (FDA) announced that ICU Medical issued an update recall to the use instructions for its Plum 360, Plum A+ and Plum A+3 infusion systems because of a manufacturing defect that can substantially diminish the life of the batteries. ICU Medical’s latest notice expands the affected products from a March 2023 notice to include all replacement batteries manufactured by CSB.

On August 19, 2024, the U.S. Food and Drug Administration (FDA) approved lazertinib (Lazcluze^™) in combination with amivantamab-vmjw (Rybrevant^®) for first-line treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution variants, as detected by an FDA-approved test.

On August 15, 2024, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi^®) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery, for adults with resectable (tumors that are 4 cm or larger or node positive) non-small cell lung cancer and no known epidermal growth factor receptor variants or anaplastic lymphoma kinase rearrangements.

On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved axatilimab-csfr (Niktimvo), a colony-stimulating factor–1 receptor-blocking antibody, for the treatment of chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.

On August 6, 2024, the U.S. Food and Drug Administration (FDA) announced that Smiths Medical is issuing a correction recall for its CADD-Solis Ambulatory Infusion Pump because of multiple issues related to outdated software. The FDA said that the recall involves correcting certain devices, not removing them from where they are used or sold. 

On August 6, 2024, the U.S. Food and Drug Administration (FDA) reported that Baxter International Inc. is voluntarily recalling one lot of heparin sodium in 0.9% sodium chloride injection to the consumer level because of the potential for elevated endotoxin levels. 

On August 6, 2024, the U.S. Food and Drug Administration approved vorasidenib (Voranigo®), an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, for adult and pediatric patients aged 12 and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 variant, following surgery including biopsy, subtotal resection, or gross total resection.

On August 2, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to afamitresgene autoleucel (Tecelra^®), a melanoma-associated antigen A4 (MAGE-A4)–directed genetically modified autologous T-cell immunotherapy, for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or -cleared companion diagnostic devices.

Increasing clinical study enrollment of participants from historically underrepresented populations helps improve the quality of data used to approve a medical product, the U.S. Food and Drug Administration (FDA) said in a June 2024 press release. To achieve that goal, the agency released draft guidance for medical product sponsors to submit required diversity action plans for phase III and other types of clinical trials.

On July 30, 2024, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro^®) in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantations.

On July 10, 2024, the U.S. Food and Drug Administration (FDA) updated the Medical Device Shortages List to include blood culture media bottles (product code MDB). It also sent a letter to healthcare providers indicating that it is aware that the United States is experiencing interruptions in the supply of BD BACTEC blood culture media bottles because of recent supplier issues. The FDA said that the supply disruption is expected to affect patient diagnosis, follow-up patient management, and antimicrobial stewardship efforts. BD previously issued a letter in June 2024 to customers identifying the affected product. 

Recent Supreme Court decisions curbing the power of federal agencies will hobble government efforts to protect public health, legal experts warn. The rulings will make it harder for some federal agencies to bring enforcement actions, give judges more leeway to second-guess agency decisions, and following a July 22, 2024, decision, make it easier to challenge long-settled regulations. Legal experts and health officials expect a gusher of litigation that will complicate the regulation of drugs, tobacco products, and cutting-edge medical technologies. The administration of government health insurance programs could be further mired in lawsuits, and decades-old agency decisions may be newly vulnerable to challenges.

On July 22, 2024, the U.S. Food and Drug Administration (FDA) reported that Hikma Pharmaceuticals USA, Inc., is extending its voluntary recall of one lot of acetaminophen injection, 1,000 mg/100 ml (10 mg/ml), to the consumer and user level. The product is being recalled because a bag labeled dexmedetomidine HCL injection (400 mcg/100 ml) may be inside an overwrap labeled as acetaminophen injection (1,000 mg/100 ml [10 mg/ml]).

A new pilot program will help the U.S. Food and Drug Administration (FDA) make transparent performance recommendations for diagnostic tests used to select certain oncology drug treatments, the agency said in a June 2024 press release. The announcement comes on the heels of FDA’s final rule regarding increased oversight and enforcement of laboratory-developed tests for conditions such as cancer.

When applied to machine learning models and other artificial intelligence (AI), the Gerchberg-Saxton algorithm more equitably and uniformly distributes a dataset’s racial and ethnic biomedical information, researchers reported in study findings published in the Journal of Healthcare Informatics Research. They demonstrated that the algorithm created parity in a group of patients spanning a broad range of population backgrounds.

To tackle the unauthorized and illegal sale and distribution of e-cigarettes and vaping products that “continue to jeopardize the health of Americans—particularly children and adolescents—across the United States,” according to Acting Associate Attorney General Benjamin C. Mizer, in June 2024 the U.S. Department of Justice and U.S. Food and Drug Administration announced the creation and launch of a new task force that brings together multiple law enforcement agencies.

The rapid advancements in oncology treatments—with new approvals in therapies like small molecules, biologics, biosimilars, and cellular therapies coming nearly every month—can be challenging for any nurse to keep up with, let alone truly understand the nuances of those approvals. As new discoveries unfold, the U.S. Food and Drug Administration (FDA) oversees the lengthy and multifaceted journey a drug or biologic takes from the laboratory to the patient. The ultimate goal of the many steps is to balance providing access to the latest treatments with ensuring patient safety.

On June 26, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to epcoritamab-bysp (Epkinly^™), a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

On June 21, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to adagrasib (Krazati^®) plus cetuximab for adults with KRAS G12C-variant locally advanced or metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

On June 17, 2024, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for adult patients with primary advanced or recurrent endometrial carcinoma.

Medicine marked a major milestone in April 2024, the U.S. Food and Drug Administration (FDA) said, when the agency announced it had approved its 50th biosimilar medication. Trastuzumab-strf, a biosimilar to the antineoplastic trastuzumab, had the honor of being the agency's 50th approval.

On June 14, 2024, the U.S. Food and Drug Administration (FDA) approved blinatumomab (Blincyto^®) for adult and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia in the consolidation phase of multiphase chemotherapy.

On June 14, 2024, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi^®) with carboplatin plus paclitaxel followed by single-agent durvalumab for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

On June 13, 2024, the U.S. Food and Drug Administration granted accelerated approval to repotrectinib (Augtyro^™) for adult and pediatric patients aged 12 and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy.

On June 12, 2024, the U.S. Food and Drug Administration (FDA) granted traditional approval to selpercatinib (Retevmo^®) for adult and pediatric patients aged 2 years and older with advanced or metastatic RET fusion–positive thyroid cancer that requires systemic therapy but is refractory to radioactive iodine (RAI), if RAI is appropriate.

On June 5, 2024, the U.S. Food and Drug Administration (FDA) announced that HomeoCare Laboratories Inc. is voluntarily recalling two batches of StellaLife oral care products to the consumer level because of the presence of microbial contamination.

On June 6, 2024, the U.S. Food and Drug Administration (FDA) approved imetelstat (Rytelo^™), an oligonucleotide telomerase inhibitor, for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks that has not responded to, has lost response to, or is ineligible for erythropoiesis-stimulating agents.

On May 29, 2024, the U.S. Food and Drug Administration (FDA) announced that Sagent Pharmaceuticals issued voluntary nationwide recall of two lots of docetaxel injection, USP (80 mg per 8 ml multidose vials and 160 mg per 16 ml multidose vials), because of the potential presence of particulate matter from the stopper in the drug product.

On May 30, 2024, the U.S. Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi^®) for adult patients with relapsed or refractory mantle cell lymphoma who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.

On May 29, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selpercatinib (Retevmo^®) for pediatric patients aged 2 and older. This is the first FDA approval of a targeted therapy for pediatric patients younger than 12 with RET alterations.

On May 16, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tarlatamab-dlle (Imdelltra™) for extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.

On May 15, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lisocabtagene maraleucel (Breyanzi^®) for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.

Nurse advocates have an incredible opportunity to represent patients and the profession in shaping the future of patient-centered pragmatic clinical trials. Through July 5, 2024, the U.S. Food and Drug Administration’s (FDA’s) Oncology Center of Excellence is crowdsourcing clinically relevant trial questions for FDA-approved therapies in its innovative Project 5 in 5 initiative.

On April 29, 2024, the U.S. Food and Drug Administration (FDA) granted traditional approval to tisotumab vedotin-tftv (Tivdak^®) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin-tftv previously received accelerated approval for the indication.

On April 23, 2024, the U.S. Food and Drug Administration (FDA) approved lutetium Lu 177 dotatate (Lutathera^®) for pediatric patients aged 12 and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors. FDA approved lutetium Lu 177 dotatate for the indication for adults in 2018.

On April 23, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tovorafenib (Ojemda™) for patients aged 6 months and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement or BRAF V600 variant.

On April 22, 2024, the U.S. Food and Drug Administration (FDA) approved nogapendekin alfa inbakicept-pmln (Anktiva^®) with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.

On April 18, 2024, the U.S. Food and Drug Administration (FDA) approved alectinib (Alecensa^®) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)–positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

On April 5, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu^®) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. It is one of seven anticancer agents with a tumor-agnostic FDA approval.

On March 27, 2024, the U.S. Food and Drug Administration (FDA) announced that Amneal Pharmaceuticals, LLC, is voluntarily recalling four lots of vancomycin hydrochloride for oral solution, USP, 250 mg/5 ml, packaged in 80 ml, 150 ml, or 300 ml pack sizes, to the consumer level.

Since 1995, the U.S. Food and Drug Administration (FDA) has received submissions for more than 300 drugs and biological products with artificial intelligence (AI) components and more than 700 AI-enabled devices, Commissioner Robert M. Califf, MD, said in a March 2024 blog post.  

On March 22, 2024, the U.S. Food and Drug Administration (FDA) fully approved mirvetuximab soravtansine-gynx (Elahere^®) for adult patients with FR alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens. Patients are selected for treatment based on an FDA-approved test. FDA gave mirvetuximab soravtansine-gynx accelerated approval for the indication in November 2022.

On March 21, 2024, the U.S. Food and Drug Administration (FDA) approved safety labeling changes regarding dihydropyrimidine dehydrogenase deficiency for fluorouracil injection products. The update was a collaboration between FDA’s Office of Generic Drugs and the Oncology Center of Excellence.

On March 19, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to ponatinib (Iclusig^®) with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia.

On March 7, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib (Brukinsa^®) with obinutuzumab for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

On March 6, 2024, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo^®) in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.

On March 5, 2024, the U.S. Food and Drug Administration (FDA) announced that Smiths Medical ASD Inc. is recalling its Medfusion model 3500 syringe pump because of issues associated with earlier software versions, including high-priority alarms during motor issues, wrong infusion restarts, screen locks, bolus interruptions, incorrect dose displays, low doses, motor errors, wrong settings recall, corrupt configurations, auto locks, and toolbox issues with loading dose time values. If a device has undetected issues, it may fail and delay, interrupt, or not deliver the therapy per the programmed setting.

On March 6, 2024, the U.S. Food and Drug Administration (FDA) approved inotuzumab ozogamicin (Besponsa^®) for pediatric patients aged 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.

On March 1, 2024, the U.S. Food and Drug Administration (FDA) approved amivantamab-vmjw (Rybrevant^®) with carboplatin and pemetrexed for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion variants, as detected by an FDA-approved test.