On February 27, 2024, the U.S. Food and Drug Administration (FDA) issued a safety communication to patients and healthcare providers about the potential risk for serious complications with BioZorb Marker and BioZorb LP Marker devices by Hologic, Inc., which are implanted in soft tissue, including breast tissue, to mark a site for medical procedures (e.g., radiation therapy for breast cancer treatment).

On February 16, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lifileucel (Amtagvi™), a tumor-derived autologous T-cell immunotherapy, for adult patients with unresectable or metastatic melanoma previously treated with a PD-1–blocking antibody and, if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor.

On February 16, 2024, the U.S. Food and Drug Administration (FDA) approved osimertinib (Tagrisso^®) with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (la/mNSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R variants, as detected by an FDA-approved test.

On February 15, 2024, the U.S. Food and Drug Administration (FDA) granted traditional approval to tepotinib (Tepmetko^®) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14–skipping alterations.

On February 14, 2024, the U.S. Food and Drug Administration (FDA) reported Smiths Medical ASD Inc.’s recall of its Medfusion model 4000 syringe pump because of issues associated with earlier software versions that may affect the alarm system, the pump, the control screen, and other parts of the pump. If undetected issues are present in the device, the device has the potential to fail and delay, interrupt, or fail to deliver the therapy per the programmed setting.

On February 13, 2024, the U.S. Food and Drug Administration approved irinotecan liposome (Onivyde^®) with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma.

In two clinical trials, patients who received fruquintinib (Fruzaqla™) had an overall survival of 7.4 and 9.3 months compared to 4.8 and 6.6 months with placebo, leading to the drug’s November 2023 U.S. Food and Drug Administration approval for adults with metastatic colorectal cancer who previously received standard chemotherapy and experienced disease progression. 

On January 19, 2024, the U.S. Food and Drug Administration (FDA) approved erdafitinib (Balversa^®) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy. Erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. The approval amends erdafitinib’s previous accelerated approval for patients with mUC with susceptible FGFR3 or FGFR2 alterations after prior platinum-containing chemotherapy.

On January 19, 2024, the U.S. Food and Drug Administration (FDA) announced that it is adding a boxed warning to the denosumab (Prolia^®) prescribing information about the significant risk of developing severe hypocalcemia in patients with advanced chronic kidney disease. The warning and new labeling contain information to help reduce that risk, including appropriately selecting patients for denosumab treatment, increased monitoring of blood calcium levels, and other strategies.

On January 12, 2024, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) with chemoradiotherapy for patients with FIGO 2014 stage III–IVA cervical cancer.

On December 20, 2023, the U.S. Food and Drug Administration (FDA) reported that Busse Hospital Disposables, Inc., had recalled its tracheostomy care tray, dressing change tray, and tracheostomy care set. Busse’s recall is in direct response to Nurse Assist LLC’s, November 6, 2023, recall of its 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, over sterility concerns, which is the only saline used in the Busse trays and kits. The recall doesn't apply to the other kit components. FDA identified it as a class I recall, where use of the devices may cause serious injuries or death.

Among U.S. high school students, current overall tobacco product use declined nearly 30% in the past year, dropping from 16.5% in 2022 to 12.6% in 2023, according to findings that the U.S. Food and Drug Administration (FDA) reported from the 2023 National Youth Tobacco Survey.

Margetuximab-cmkb (Margenza^®) received U.S. Food and Drug Administration approval in December 2020 for previously treated adults with metastatic HER2-positive breast cancer after clinical trials demonstrated increased progression-free and overall survival. 

On December 15, 2023, the U.S. Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv (Padcev^®) in combination with pembrolizumab (Keytruda^®) for patients with locally advanced or metastatic urothelial cancer (la/mUC). FDA previously granted the combination accelerated approval for patients with la/mUC who are ineligible for cisplatin-containing chemotherapy.

On December 15, 2023, the U.S. Food and Drug Administration (FDA) published a public update about its work to strengthen safety requirements and consumer communication about risks surrounding breast implants. Through the following actions, FDA said it intended to support patient-provider discussions and shared decision-making for breast implants.

On December 14, 2023, the U.S. Food and Drug Administration (FDA) approved belzutifan (Welireg™) for patients with advanced renal cell carcinoma following treatment with a programmed death receptor-1 or programmed death-ligand 1 inhibitor and a vascular endothelial growth factor–tyrosine kinase inhibitor (VEGF-TKI).

On December 13, 2023, the U.S. Food and Drug Administration (FDA) approved eflornithine (Iwilfin™) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who demonstrated at least a partial response to prior multiagent, multimodality therapy, including anti-GD2 immunotherapy. This represents the first FDA approval of a therapy intended to reduce the risk of relapse in pediatric patients with HRNB.

On December 1, 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib (Jaypirca™) for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

On November 27, 2023, the U.S. Food and Drug Administration (FDA) reported that Novartis is conducting a voluntary nationwide recall at the consumer level of two lots of its Sandimmune^® Oral Solution (cyclosporine oral solution, USP), 100 mg/ml, in the United States because of crystal formation observed in some bottles that could result in incorrect dosing. The issue was identified during an investigation of crystallization in a different lot of cyclosporine oral solution, USP, 100 mg/m. No other Sandimmune formulations are affected.

On November 28, 2023, the U.S. Food and Drug Administration (FDA) issued a safety communication to patients and healthcare professionals regarding BCMA- or CD19-directed autologous CAR T-cell immunotherapies. The agency said it received reports of T-cell malignancies, including CAR-positive lymphoma, in patients who received treatment with those products. The reports came from clinical trials and postmarketing adverse event data sources.

On November 27, 2023, the U.S. Food and Drug Administration (FDA) approved nirogacestat (Ogsiveo™) for use in adult patients with progressing desmoid tumors who require systemic treatment. Nirogacestat is the first approved treatment for desmoid tumors.

After an open-label, multicenter, single-arm trial demonstrated a 56% objective response rate, with 43% achieving complete responses, and an estimated 18.4-month median duration of response, the U.S. Food and Drug Administration granted glofitamab-gxbm (Columvi™) accelerated approval in June 2023. 

On November 21, 2023, the U.S. Food and Drug Administration (FDA) advised that Bayer issued a voluntary recall for one lot of larotrectinib (Vitrakvi^®) oral solution 20 mg/ml in 100 ml glass bottles to the user level because of Penicillium brevicompactum microbial contamination observed during routine stability testing.

On November 20, 2023, the U.S. Food and Drug Administration (FDA) alerted healthcare providers and facilities not to use Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia (PCA) pumps while the agency further evaluates a reported issue. FDA classified it as a class I recall, the most serious type of recall, where use of the product or device may result in serious injury or death.

On November 17, 2023, the U.S. Food and Drug Administration (FDA) announced that B. Braun Medical, Inc., is recalling its Infusomat Space Volumetric Infusion Pump System because of faulty occlusion alarms, causing the pump to stop delivering medications, including high-risk medications such as vasopressors. Interrupting the infusion of high-risk medications may lead to hemodynamic instability, which may be life-threatening or lead to death in some cases. FDA is aware of 51 reports, one injury, and one death related to the recall. The agency has identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.

On November 16, 2023, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi^®) for non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.

On November 16, 2023, the U.S Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) with fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.

On November 16, 2023, the U.S. Food and Drug Administration (FDA) approved capivasertib (Truqap™) with fulvestrant for adult patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. FDA also approved the FoundationOne^®CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with capivasertib with fulvestrant.

On November 15, 2023, the U.S. Food and Drug Administration (FDA) approved repotrectinib (Augtyro™) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). This is the first FDA approval for treatment of patients with ROS1-positive NSCLC who have previously received a ROS1 tyrosine kinase inhibitor (TKI), in addition to patients who are TKI naïve.

On November 15, 2023, the U.S. Food and Drug Administration (FDA) reported that Fresenius Medical Care is recalling three types of its Sanxin single-use syringes because of leakages. FDA identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.

On November 7, 2023, the U.S. Food and Drug Administration (FDA) revised the existing indication of pembrolizumab (Keytruda^®) with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. This updated indication, which remains approved under accelerated approval regulations, restricts its use to patients whose tumors express PD-L1 (CPS ≥ 1), as determined by an FDA-approved test.

On November 8, 2023, the U.S. Food and Drug Administration (FDA) approved fruquintinib (Fruzaqla™) for adult patients with metastatic colorectal cancer who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.

On November 6, 2023, the U.S. Food and Drug Administration (FDA) announced that Teleflex, and its subsidiary Arrow International, are recalling 1,905 pressure injectable central venous catheter kits due to mislabeling regarding the presence of chlorhexidine in these products. FDA has identified it as a class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

On November 6, 2023, the U.S. Food and Drug Administration (FDA) announced Nurse Assist, LLC’s, recall and warned consumers, healthcare providers, and healthcare facilities not to use recalled saline (0.9% sodium chloride) and sterile water medical products manufactured by Nurse Assist, LLC, and sold under various brands, because they may not be sterile.

On October 31, 2023, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) used with gemcitabine and cisplatin for the treatment of locally advanced unresectable or metastatic biliary tract cancer.

On October 27, 2023, the U.S. Food and Drug Administration (FDA) approved toripalimab-tpzi (Loqtorz) with cisplatin and gemcitabine for first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC). FDA also approved toripalimab-tpzi as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.

On October 25, 2023, the U.S. Food and Drug Administration (FDA) announced that Exela Pharma Sciences, LLC (Exela), is voluntarily recalling the following products to the consumer level because it observed silicone particulate matter during routine inspection of retained samples.

On October 24, 2023, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo^®) for the treatment of adult patients with relapsed or refractory myelodysplastic syndrome (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) variant, as detected by an FDA-approved test. The agency also approved the Abbott RealTime IDH1 assay as a companion diagnostic device to select patients for ivosidenib treatment.

After a single-arm clinical trial demonstrated an overall response rate of 31.7% in 106 patients with folate receptor (FR) alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, the U.S. Food and Drug Administration granted mirvetuximab soravtansine-gynx (Elahere^®) accelerated approval on November 14, 2022.  

On October 20, 2023, the U.S Food and Drug Administration (FDA) granted accelerated approval to entrectinib (Rozlytrek^®) for pediatric patients older than 1 month with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance variant, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy. In August 2019, FDA granted entrectinib accelerated approval for pediatric patients aged 12 years or older for the indication.

On October 16, 2023, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) with platinum-containing chemotherapy as neoadjuvant treatment and with continuation of single-agent pembrolizumab as postsurgical adjuvant treatment for resectable (tumors ≥ 4 cm or node positive) non-small cell lung cancer (NSCLC).

On October 13, 2023, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo^®) for the adjuvant treatment of completely resected stage IIB/C melanoma in patients aged 12 years and older.

On October 11, 2023, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi^®) with binimetinib (Mektovi^®) for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E variant, as detected by an FDA-approved test.

On October 2, 2023, the U.S. Food and Drug Administration reported Hospira, Inc.’s, voluntary recall of several lots of 4.2% sodium bicarbonate injection, USP, 5 mEq/10 ml vial; 1% lidocaine HCl injection, USP, 50 mg/5 ml vial; and 2% lidocaine HCl injection, USP, 100 mg/5 ml vial to the user level because of the potential for presence of glass particulate matter.

On September 29, 2023, the U.S. Food and Drug Administration (FDA) issued an updated safety communication to consumers, healthcare providers, and facilities about certain surgical N95 respirators and masks manufactured by Owens and Minor (O&M) Halyard. FDA updated its recommendations for the products based on new data and information from O&M Halyard.  

On September 26, 2023, the U.S. Food and Drug Administration (FDA) approved bosutinib (Bosulif^®) for pediatric patients aged 1 year and older with chronic phase Ph+ chronic myelogenous leukemia that is newly diagnosed or resistant or intolerant to prior therapy. FDA also approved a new 50 mg and 100 mg capsule dosage form.

In August 2022, the U.S. Food and Drug Administration granted regular approval to capmatinib (Tabrecta®) for adults with metastatic non-small cell lung cancer whose tumors have a variant that leads to mesenchymal-epithelial transition exon 14 skipping. Capmatinib was granted accelerated approval for the same indication in May 2020; the regular approval in August 2022 was based on additional data from 63 patients and follow-up data establishing durability of response and clinical benefit.

On September 20, 2023, the U.S. Food and Drug Administration (FDA) announced that Medline Industries had recalled a single lot of Hudson RCI AddiPak^® unit dose vial, 0.9% full normal saline solution, because it may be nonsterile. FDA identified it as a class I recall, the most serious type of recall, where usage may cause serious injuries or death.