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.

On September 14, 2023, the U.S. Food and Drug Administration (FDA) approved new labeling for temozolomide (Temodar^®) under Project Renewal, an Oncology Center of Excellence (OCE) initiative that updates labeling information for older oncology drugs to ensure it is clinically meaningful and scientifically current. This is the second drug—both anticancer agents—to receive a labeling update under the pilot program. The first was for capecitabine (Xeloda^®).

On September 11, 2023, the U.S. Food and Drug Administration announced Novartis’s voluntary nationwide recall at the consumer level of one lot of its Sandimmune^® Oral Solution (cyclosporine oral solution, USP), 100 mg/ml, in the United States because of observations of crystals in some bottles that could result in incorrect dosing. No other cyclosporine oral solution formulations are affected.

U.S. Representatives Diana DeGette (D-CO) and Debbie Wasserman Schultz (D-FL), along with more than 50 members of the U.S. Congress, wrote a letter in June 2023 calling on the U.S. Food and Drug Administration (FDA) to abide by a court-ordered deadline to review outstanding Premarket Tobacco Product Applications for e-cigarette products that remain on the market without approval. The call comes after FDA failed to meet the initial deadline of September 9, 2021, to complete its review of all pending e-cigarette applications.

In its annual report to the U.S. Congress on drug shortages, the U.S. Food and Drug Administration cited the COVID-19 pandemic, supply chain problems, and approval processes as reasons for the shortages during the 2022 calendar year.

In a record number of outreaches, the U.S. Food and Drug Administration issued warning letters in June 2023 to 189 retailers for selling unauthorized tobacco products. Two notable brands included in the warning, Elf Bar and Esco Bars, sell disposable e-cigarettes that come in flavors that appeal to youth, such as bubblegum and cotton candy.

On August 14, 2023, the U.S. Food and Drug Administration approved melphalan (Hepzato™) for injection or hepatic delivery system (Hepzato Kit) containing melphalan as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

On August 14, 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to elranatamab-bcmm (Elrexfio™), a bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

On August 11, 2023, the U.S. Food and Drug Administration (FDA) approved the fixed dose combination of niraparib and abiraterone acetate (Akeega^™) plus prednisone for adult patients with deleterious or suspected deleterious BRCA variant metastatic castration-resistant prostate cancer, as determined by an FDA-approved test.

On August 9, 2023, the U.S. Food and Drug Administration granted accelerated approval to talquetamab-tgvs (Talvey^™) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

On August 9, 2023, the U.S. Food and Drug Administration (FDA) granted regular approval to pralsetinib (Gavreto^®) for adult patients with metastatic, rearranged during transfection fusion-positive non-small cell lung cancer as detected by an FDA-approved test.

On August 2, 2023, the U.S. Food and Drug Administration (FDA) approved trifluridine and tipiracil (Lonsurf®) with bevacizumab, for metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biologic therapy, and if RAS wild-type, an anti-EGFR therapy. FDA had previously approved single-agent trifluridine and tipiracil for the indication in September 2015.

On August 1, 2023, the U.S. Food and Drug Administration (FDA) reported Baxter Healthcare Corporation’s June 15, 2023, recall of SIGMA Spectrum infusion pumps with master drug library (version 8) and Spectrum IQ infusion systems with dose IQ safety software (version 9) because of false alarms for upstream occlusion after pump software upgrades to version v8.01.01 and v9.02.01, respectively. 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 July 31, 2023, the U.S. Food and Drug Administration approved dostarlimab-gxly (Jemperli) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent endometrial cancer that is mismatch repair deficient, as determined by an FDA-approved test, or microsatellite instability-high.

After clinical trials demonstrated a 43% durable objective response rate with a median 8.5-month duration, the U.S. Food and Drug Administration (FDA) granted adagrasib (Krazati™) accelerated approval in December 2022 for adult patients with locally advanced or metastatic non-small cell lung cancer with a KRAS G12C variant, as detected by an FDA-approved test, whose disease has progressed on or after at least one prior systemic therapy.

On July 20, 2023, the U.S. Food and Drug Administration (FDA) approved quizartinib (Vanflyta®) in combination with standard cytarabine and anthracycline induction and cytarabine consolidation and as maintenance monotherapy following consolidation chemotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukemia that are FLT3 internal tandem duplication-positive, as detected by an FDA-approved test. FDA also approved the LeukoStrat CDx FLT3 variant assay as a companion diagnostic for quizartinib.

After clinical trial outcomes demonstrated a statistically significant difference in progression-free survival in a subgroup of patients with estrogen receptor-positive, HER2-negative, ESR1-altered disease, the U.S. Food and Drug Administration granted elacestrant’s (Orserdu™) application priority review and fast-track designation, with regular approval in January 2023.   

Ushering in a new field of study called tobacco regulatory research, the U.S. Food and Drug Administration’s Tobacco Regulatory Science Program (TRSP) funded its first 14 Tobacco Centers of Regulatory Science in 2013. Ten years later, David M. Murray, PhD, associate director of the National Institutes of Health’s Office of Disease Prevention, highlighted TRSP’s decade of research discoveries—but reinforced the need for continued research and advocacy on tobacco use.

With an estimated duration of response rate of 90.6% at six months and 66.5% at nine months in the agent’s clinical trials, in October 2022, the U.S. Food and Drug Administration granted accelerated approval to teclistamab-cqyv (Tecvayli™) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four previous lines of therapy.  

On June 20, 2023, the U.S. Food and Drug Administration approved talazoparib (Talzenna®) with enzalutamide for homologous recombination repair gene–variant metastatic, castration-resistant prostate cancer.

On June 15, 2023, the U.S. Food and Drug Administration granted accelerated approval to glofitamab-gxbm (Columvi™) for relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy.

On June 14, 2023, the U.S. Food and Drug Administration reported that the Harvard Drug Group, LLC, conducting business as Major Pharmaceuticals and Rugby Laboratories, issued a voluntary recall of a single lot of dronabinol capsules, USP, 2.5 mg, and ziprasidone hydrochloride capsules, 20 mg, after receiving a report that some unit dose cartons labeled as ziprasidone hydrochloride capsules, 20 mg, contained blister packages labeled as and containing dronabinol capsules, USP, 2.5 mg.