On May 31, 2023, the U.S. Food and Drug Administration approved olaparib (Lynparza^®) plus abiraterone and prednisone or prednisolone for adult patients with deleterious or suspected deleterious BRCA variant, metastatic, castration-resistant prostate cancer, as determined by an FDA-approved companion diagnostic test.

On May 22, 2023, the U.S. Food and Drug Administration (FDA) reported ICU Medical’s recall of replacement batteries for its Plum 360™, Plum A+™, and Plum A+3 infusion systems because of a manufacturing defect that can substantially diminish how long the batteries can run the system. FDA identified it as a class I recall, the most serious type of recall, where use may cause serious injuries or death.

In an open-label, multicenter, multicohort study that included 90 patients with relapsed or refractory follicular lymphoma who had received at least two prior lines of systemic therapy, 60% of patients receiving treatment with mosunetuzumab-axgb achieved a complete response and 80% had an overall response. On December 22, 2022, the U.S. Food and Drug Administration granted mosunetuzumab-axgb accelerated approval based on those findings.

On May 19, 2023, the U.S. Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly®) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.

In an attempt to strongly regulate the e-cigarettes and vapes industry, the U.S. Food and Drug Administration filed civil money penalty complaints against four tobacco product manufacturers for manufacturing and selling e-liquid products without authorization. The action marks the first time FDA has filed CMP complaints against tobacco product manufacturers to enforce the Federal Food, Drug, and Cosmetic Act’s premarket review requirements for new tobacco products. 

On April 27, 2023, the U.S. Food and Drug Administration reported that Teva Pharmaceuticals USA, Inc., issued a voluntary recall of certain lots of fentanyl buccal tablets, a schedule II substance, to the consumer level because safety updates were omitted in the lots’ product insert/medication guide. Teva Pharmaceuticals USA, Inc., manufactured and labeled the product lots exclusively for Mayne Pharma, Inc.

Under the U.S. Food and Drug Administration’s (FDA’s) fast-track approval process, nadofaragene firadenovec-vncg (Adstiladrin®) became the first gene therapy approved for the treatment of high-risk non-muscle invasive bladder cancer. Approximately 75% of newly diagnosed bladder cancers are classified as non-muscle invasive. Bacillus Calmette Guérin has been used as first-line therapy for more than 20 years, but eventually 30%–50% of patients stop responding, and nadofaragene firadenovec-vncg offers a new treatment option. FDA’s December 2022 approval was based on complete response (CR) and duration of response from Study CS-003, which demonstrated a 46% CR for at least one year.

On April 19, 2023, the U.S. Food and Drug Administration approved polatuzumab vedotin-piiq (Polivy®) with rituximab, cyclophosphamide, doxorubicin, and prednisone for adult patients who have previously untreated diffuse large B-cell lymphoma, not otherwise specified, or high-grade B-cell lymphoma and who have an International Prognostic Index score of 2 or greater.

On April 17, 2023, the U.S. Food and Drug Administration approved omidubicel-onlv (Omisirge^®) for use in adult and pediatric patients aged 12 years and older with hematologic malignancies receiving umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.

On April 12, 2023, the U.S. Food and Drug Administration issued a safety communication to healthcare providers, institutions, and consumers recommending that they do not use certain surgical N95 respirators manufactured by Owens and Minor Halyard and that they use certain surgical masks and pediatric face masks from Owens and Minor Halyard with caution. The recommendation comes after the masks failed fluid resistance performance tests. 

On April 3, 2023, the U.S. Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev®) with pembrolizumab (Keytruda®) for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.

Taking into consideration the history of HIV/AIDS and upholding COVID-19–related guidelines, the U.S. Food and Drug Administration proposed adjusting blood donor eligibility from time-based deferrals to assessing donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV.

When the U.S. Food and Drug Administration (FDA) granted pemigatinib (Pemazyre®) a new indication in August 2022, it became the first targeted therapy approved for treatment of patients with relapsed or refractory myeloid or lymphoid neoplasms (MLNs) with fibroblast growth factor receptor (FGFR) 1 rearrangement. In 2021, FDA gave pemigatinib accelerated approval for patients with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement as detected by an FDA-approved test.

On March 22, 2023, the U.S. Food and Drug Administration granted accelerated approval to retifanlimab-dlwr (Zynyz®) for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.

The U.S. Food and Drug Administration updated its mammography regulations in March 2023 to require institutions to notify patients about their breast density. The updated regulations strengthen FDA’s oversight and enforcement of institutions and help healthcare providers better categorize and assess mammograms.

On March 16, 2023, the U.S. Food and Drug Administration approved dabrafenib (Tafinlar®) with trametinib (Mekinist®) for pediatric patients aged one year and older with low-grade glioma (LGG) that have a BRAF V600E variant who require systemic therapy. FDA also approved new oral formulations of both drugs for patients who cannot swallow pills. It is the first FDA approval of a systemic therapy for first-line treatment of pediatric patients with LGG that have a BRAF V600E variant.

On March 3, 2023, the U.S. Food and Drug Administration approved abemaciclib (Verzenio®) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer who are at high risk for recurrence.

Patients with rare cancers like intrahepatic cholangiocarcinoma seldom have many additional treatment options if their tumors become resistant to first-line therapy: From August 1, 2021–July 31, 2022, the U.S. Food and Drug Administration approved only five new agents or indications for rare tumors. On September 30, 2022, FDA added one more, giving futibatinib (Lytgobi™) accelerated approval for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangements. The approval was based on the drug’s 42% overall response rate and median duration of response of 9.7 months.

On February 9, 2023, the U.S. Food and Drug Administration approved dostarlimab-gxly (Jemperli®) for adult patients with mismatch repair deficient recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.

On February 2, 2023, the U.S. Food and Drug Administration reported Smiths Medical’s recall of its CADD™ infusion system administration sets and cassette reservoirs because of tubing occlusions that may under- or not deliver medication and false no disposable attached alarms that may prevent pump use. FDA identified it as a class I recall, the most serious type of recall, where use may cause serious injuries or death.

On February 3, 2023, the U.S. Food and Drug Administration approved sacituzumab govitecan-hziy (Trodelvy®) for unresectable locally advanced or metastatic hormone receptor–positive, human epidermal growth factor receptor 2–negative (IHC 0, IHC 1+, or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

On January 27, 2023, the U.S. Food and Drug Administration approved elacestrant (Orserdu®) for postmenopausal women or adult men with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-variant advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

On January 26, 2023 the U.S. Food and Drug Administration removed its emergency use authorization of tixagevimab/cilgavimab (Evushield) for the prevention of SARS-CoV-2 infection after exposure to the virus. FDA said it made the decision because the agent is not effective in preventing infections from the current variants that are responsible for 90% of today’s infections and because the risks of the drug’s side effects do not outweigh the benefits.

On January 26, 2023, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda®) for adjuvant treatment following resection and platinum-based chemotherapy of patients with stage IB (T2a ≥ 4 cm), II, or IIIA non-small cell lung cancer.

On January 27, 2023, the U.S. Food and Drug Administration granted accelerated approval to pirtobrutinib (Jaypirca®) for relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor.

On August 5, 2022, the U.S. Food and Drug Administration approved darolutamide (Nubeqa®) in combination with docetaxel in adults with metastatic hormone-sensitive prostate cancer. The approval was based on clinical trial findings demonstrating that the agent improved overall survival and significantly delayed time to pain progression compared to placebo.

On January 19, 2023, the U.S. Food and Drug Administration approved zanubrutinib (Brukinsa®) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

On January 19, 2023, the U.S. Food and Drug Administration granted accelerated approval to tucatinib (Tukysa®) in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

On January 5, 2022, the U.S. Food and Drug Administration reported that Smiths Medical issued a December 12, 2022, urgent medical device correction letter to notify customers of two potential issues with CADD infusion system infusion sets because of potential under or no delivery and false no-disposable-attached alarms.

On January 9, 2022, the U.S. Food and Drug Administration reported that Spectrum Laboratory Products, Inc., issued a voluntarily recall of three lots of epinephrine (l-adrenaline), USP, used to manufacture or compound prescription products, at the user level because of customer reports that the product is discolored.

On December 22, 2022, the U.S. Food and Drug Administration granted accelerated approval to mosunetuzumab-axgb (Lunsumio®), a bispecific, CD20-directed, CD3 T-cell engager for adult patients with relapsed or refractory follicular lymphoma who’ve received two or more lines of systemic therapy.

On December 22, 2022, the U.S. Food and Drug Administration reported that Hospira, Inc., a Pfizer company, issued a voluntarily recall of one lot of vancomycin hydrochloride injection, USP, 1.5 g, single-dose flip-top vial, at the consumer level. Hospira, Inc., issued the recall because a report of two glass particulates observed in a single vial.

On December 22, 2022, the U.S. Food and Drug Administration (FDA) reported Accord Healthcare, Inc.’s, voluntarily recall of a single lot of daptomycin for injection 500 mg and 350 mg vials at the consumer level because vials labeled as “daptomycin for injection 500 mg/vial” were found in cartons labeled “daptomycin for injection 350 mg/vial.”

On December 16, 2022, the U.S. Food and Drug Administration approved nadofaragene firadenovec-vncg (Adstiladrin®) for adult patients with high-risk, Bacillus Calmette-Guérin unresponsive, carcinoma in situ, non–muscle-invasive bladder cancer with or without papillary tumors.

On December 14, 2022, the U.S. Food and Drug Administration approved updated labeling for capecitabine tablets (Xeloda®) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date. Capecitabine is the first drug to receive a labeling update under the pilot program.

On December 12, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to adagrasib (Krazati^®), a RAS GTPase family inhibitor, for adult patients with KRAS G12C–variant locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, and who have received at least one prior systemic therapy.

On December 9, 2022, the U.S. Food and Drug Administration approved atezolizumab (Tecentriq®) for adult and pediatric patients aged 2 years and older with unresectable or metastatic alveolar soft part sarcoma.

On December 1, 2022, the U.S. Food and Drug Administration approved olutasidenib (Rezlidhia^®) capsules for adult patients with relapsed or refractory acute myeloid leukemia with susceptible IDH1 variants as detected by an FDA-approved test. FDA also approved the Abbott RealTime IDH1 Assay to identify patients who are appropriate for olutasidenib.

On November 18, 2022, the U.S. Food and Drug Administration approved a Monday-Wednesday-Friday dosing option for asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze®). Under the alternative regimen, patients receive 25 mg/m² intramuscularly on Monday and Wednesday mornings and 50 mg/m² intramuscularly on Friday afternoons. It also is approved at a dose of 25 mg/m² intramuscularly every 48 hours.

On November 10, 2022, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (Adcetris®) plus doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients aged two years and older with previously untreated, high-risk classical Hodgkin lymphoma. This is the first pediatric approval for brentuximab vedotin.

On November 14, 2022, the U.S. Food and Drug Administration granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere®) for adult patients with folate receptor alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, as detected with an FDA-approved test, who received one to three prior systemic treatment regimens. Mirvetuximab soravtansine-gynx is a FR alpha–directed antibody and microtubule inhibitor conjugate. FDA also approved the VENTANA FOLR1 (FOLR-2.1) RxDx Assay (Ventana Medical Systems, Inc.) as a companion diagnostic device to identify patients for the indication.

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, filed complaints for permanent injunctions against six e-cigarette manufacturers in October 2022. It was the first time FDA initiated injunction proceedings to enforce review requirements for new tobacco products.

To better reflect product descriptions and enforce commitment to diversity and inclusion, the U.S. Food and Drug Administration’s Center for Tobacco Products updated its term “grandfathered tobacco product” to “pre-existing tobacco product” in August 2022.

On November 10, 2022, the U.S. Food and Drug Administration approved tremelimumab (Imjudo®) in combination with durvalumab (Imfinzi®) and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer with no sensitizing epidermal growth factor receptor (EGFR) variant or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

On October 31, 2022, the U.S. Food and Drug Administration alerted patients, caregivers, and healthcare providers of a tracheostomy tube shortage, including Bivona tracheostomy tubes manufactured by ICU Medical, because of difficulty obtaining required raw materials. FDA said it is working with manufacturers and other stakeholders to help resolve supply challenges and support the devices’ availability.

On October 31, 2022, the U.S. Food and Drug Administration recommended that healthcare providers discuss alternative options for magnetic resonance imaging–guided breast biopsy procedures with patients if a facility is unable to perform it because of a shortage of Philips Invivo MRI breast biopsy grid plates and other Philips Invivo MRI disposables. 

About 1 in 10 middle (3.3%) and high (14.1%) school students used e-cigarettes in the past 30 days, according to findings that the U.S. Food and Drug Administration, in coordination with the Centers for Disease Control and Prevention, reported in October 2022. In total, 2.5 million middle and high school students currently use e-cigarettes.

On October 25, 2022, the U.S. Food and Drug Administration granted accelerated approval to teclistamab-cqyv (Tecvayli®), the first bispecific B-cell maturation antigen–directed CD3 T-cell engager, for adult patients 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 October 21, 2022, the U.S. Food and Drug Administration approved tremelimumab (Imjudo®) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma.

On October 13, 2022, the U.S. Food and Drug Administration reported Exela Pharma Sciences, LLC’s, voluntary recall of 49 lots of sodium bicarbonate injection, USP, 8.4%, 50 mEq/50 ml vial, 20-count carton, to the consumer level because of potential vial breakage and flying glass when pressurized while preparing for administration.