On September 22, 2022, to help achieve its priority of expanding the availability of overdose reversal products, the U.S. Food and Drug Administration issued the Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency industry guidance.

On September 21, 2022, the U.S. Food and Drug Administration (FDA) granted regular approval to selpercatinib (Retevmo®) for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion and accelerated approval for adults with locally advanced or metastatic solid tumors with a RET gene fusion that progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

On September 20, 2022, the U.S. Food and Drug Administration (FDA) approved the use of sodium thiosulfate (Pedmark®) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients aged 1 month and older with localized, nonmetastatic solid tumors.

On September 15, 2022, the U.S. Food and Drug Administration reported Baxter Healthcare Corporation’s recall of Clearlink basic solution set with Duovent because of reports of leaks. FDA identified it as a class I recall, the most serious type of recall, where use of the set may cause serious injuries or death.

On September 8, 2022, the U.S. Food and Drug Administration reported that cancers, including squamous cell carcinoma and various lymphomas, may develop in the capsule that forms around breast implants.

On September 2, 2022, the U.S. Food and Drug Administration approved durvalumab (Imfinzi®) in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer.

On August 26, 2022, the U.S. Food and Drug Administration approved pemigatinib (Pemazyre®) for adults with relapsed or refractory myeloid or lymphoid neoplasms with fibroblast growth factor receptor 1 rearrangement.

On August 29, 2022, the U.S. Food and Drug Administration reported Intera Oncology’s recall of the Intera 3000 hepatic artery infusion pump because of reports that the devices were delivering medications faster than expected. FDA identified it as a class I recall, the most serious type of recall, where use of the device may cause serious injuries or death.

On August 24, 2022, the U.S. Food and Drug Administration approved ibrutinib (Imbruvica®) for pediatric patients aged less than 1 year with chronic graft-versus-host disease after failure of one or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension.

The U.S. Food and Drug Administration must pull all unauthorized synthetic nicotine products from the market, Robin Koval, CEO and president of Truth Initiative, said in a July 2022 statement.

On August 11, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu®) for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 (HER2) variants, as detected by an FDA-approved test, and who have received a prior systemic therapy. This is the first drug approved for HER2-variant NSCLC.

On August 10, 2022, the U.S. Food and Drug Administration (FDA) granted regular approval to capmatinib (Tabrecta®) for adult patients with metastatic non-small cell lung cancer whose tumors have a mutation leading to mesenchymal-epithelial transition exon 14 skipping, as detected by an FDA-approved test.

To raise awareness and better educate patients and providers about biosimilars’ potential in clinical care, the U.S. Food and Drug Administration (FDA) added three new fact sheets to its healthcare provider resources in July 2022.

E-cigarette marketing application reviews won’t conclude until June 2023, the U.S. Food and Drug Administration (FDA) said in a status report in May 2022, sparking frustration among healthcare advocates.

On August 5, 2022, the U.S. Food and Drug Administration (FDA) approved darolutamide (Nubeqa®) tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer.

On August 5, 2022, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu®) for use in adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH‑) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

On June 21, 2022, the U.S. Food and Drug Administration (FDA) reported Vi-Jon, LLC’s, voluntarily recall of one lot of CVS magnesium citrate saline laxative oral solution lemon flavor, 10 fl oz (296 ml), after testing revealed the product contains the bacteria Gluconacetobacter liquefaciens.

On July 25, 2022, the U.S. Food and Drug Administration (FDA) reported Baxter Healthcare Corporation’s recall of the Abacus order entry and calculation software because of a printing error that could cause final bag labels for compounded mixtures to be incorrect. FDA identified it as a class I recall, the most serious type of recall, where use of the software may cause serious injuries or death.

Under its authority to regulate vaping and e-cigarettes, the U.S. Food and Drug Administration (FDA) ordered JUUL Labs Inc. to stop selling and remove all of its current products from the market after the company’s applications failed to provide sufficient evidence about the products’ toxicologic profiles.

On July 20, 2022, the U.S. Food and Drug Administration (FDA) reported Smiths Medical’s recall of its Medfusion 3500 and 4000 syringe infusion pumps because of software malfunctions. 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 14, 2022, the U.S. Food and Drug Administration (FDA) approved crizotinib (Xalkori®) for adult and pediatric patients aged 1 and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT).

As part of ongoing efforts to protect adolescents from tobacco, the U.S. Food and Drug Administration (FDA) launched an education campaign to prevent e-cigarette use and vaping among America Indian and Alaska Native youth in June 2022.

To improve safety and regulation for drugs and devices, U.S. Senators Patty Murray (D-WA) and Richard Burr (R-NC) introduced the Safety and Landmark Advancements (FDASLA) Act in May 2022. The act reauthorizes and builds on the U.S. Food and Drug Administration’s (FDA’s) prescription drug, generic drug, biosimilar, and medical device user fee agreements.

On June 30, 2022, the U.S. Food and Drug Administration issued a drug safety communication for duvelisib (Copiktra^®) after results from a clinical trial showed a possible increased risk of death associated with the agent, which is approved for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL who have received at least two prior therapies. The clinical trial results also associated duvelisib with a higher risk of serious side effects, including infections, diarrhea, lung and intestinal inflammation, skin reactions, and elevated liver enzymes.

On June 28, 2022, the U.S. Food and Drug Administration (FDA) reported Bryant Ranch Prepack Inc.’s voluntarily recall of one lot of morphine sulfate 30 mg extended-release tablets and one lot of morphine sulfate 60 mg extended-release tablets because the products are incorrectly labeled. Bottles labeled as 60 mg tablets may contain 30 mg tablets and bottles labeled as 30 mg may have 60 mg tablets.

On June 24, 2022, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel (Breyanzi®) for adult patients with large B-cell lymphoma (LBCL) whose disease is refractory to first-line chemoimmunotherapy, have relapsed within a year of first-line chemoimmunotherapy, or are not eligible for hematopoietic stem cell transplantation (HSCT) after relapse. It is not for patients with primary central nervous system lymphoma.

On June 22, 2022, the U.S. Food and Drug Administration (FDA) reported Becton, Dickinson and Company’s (BD’s) voluntary recall of its intraosseous needle set kits, manual driver kits, and powered drivers. Use of the products could lead to needlestick injuries or delays in care because of limited or non-functioning intraosseous access.

More than a year and a half after a report suggesting a potential racial bias in pulse oximeter technology first surfaced as a letter to the editor in the New England Journal of Medicine (NEJM), on June 21, 2022, the U.S. Food and Drug Administration (FDA) said that it is continuing its investigation into the devices’ accuracy and performance, particularly among people of color.

The U.S. Food and Drug Administration (FDA) proposed two product standards in April 2022 aimed at banning flavored tobacco and menthol products. According to FDA, the proposed product standard would “reduce the appeal of cigarettes, particularly to youth and young adults, and thereby decrease the likelihood that nonusers who would otherwise experiment with menthol cigarettes would progress to regular smoking.” 

On June 8, 2022, the U.S. Food and Drug Administration (FDA) reported Plastikon Healthcare's voluntarily recall of one lot of Milk of Magnesia 2,400 mg/10 ml oral suspension, one lot of Milk of Magnesia 2,400 mg/30 ml oral suspension, 11 lots of magnesium hydroxide 1,200 mg/aluminum hydroxide 1,200 mg/simethicone 120 mg per 30 ml oral suspension, and two lots of magnesium hydroxide 2,400 mg/aluminum hydroxide 2,400 mg/simethicone 240 mg per 30 ml oral suspension to the consumer level because of microbial contamination.

On June 2, 2022, the U.S. Food and Drug Administration (FDA) reported a cybersecurity vulnerability that affects software in the Illumina NextSeq 550Dx, MiSeqDx, NextSeq 500, NextSeq 550, MiSeq, iSeq, and MiniSeq next generation sequencing instruments. The devices are used in diagnostic (Dx), research-use only (RUO), or dual boot (either Dx or RUO) modes. 

Because of safety concerns, the U.S. Food and Drug Administration (FDA) withdrew its approval of umbralisib (Ukoniq^®) on June 1, 2022. Umbralisib had been approved to treat marginal zone lymphoma (MZL) and follicular lymphoma (FL).

On May 27, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisagenlecleucel (Kymriah^®) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

On May 27, 2022, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo^®) in combination with fluoropyrimidine- and platinum-based chemotherapy and nivolumab in combination with ipilimumab (Yervoy^®) for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC).

New draft guidance from the U.S. Food and Drug Administration (FDA) facilitates enrolling more participants from underrepresented racial and ethnic U.S. populations into industry clinical trials. According to FDA, despite their disproportionate burden for certain diseases, racial and ethnic minorities are frequently underrepresented in research and expanding diversity in clinical trials is an important step to reduce those disparities.

On May 25, 2022, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo^®) in combination with azacitidine for patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 variant as detected by an FDA-approved test in adults aged 75 years or older or those who have comorbidities that preclude use of intensive induction chemotherapy.

On May 20, 2022, the U.S. Food and Drug Administration (FDA) approved azacitidine (Vidaza^®) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML).

On May 4, 2022, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu^®) for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2–based regimen in the metastatic setting as well as those in the neoadjuvant or adjuvant setting who developed disease recurrence during or within six months of completing therapy.

On April 5, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to alpelisib (Vijoice^®) for adult and pediatric patients aged two and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy.

On April 1, 2022, the U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel (Yescarta^®) for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for the treatment of patients with primary central nervous system lymphoma.

On March 23, 2022, the U.S. Food and Drug Administration (FDA) approved lutetium lu 177 vipivotide tetraxetan (Pluvicto™) for adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR)–pathway inhibition and taxane-based chemotherapy. 

On March 21, 2022, the U.S. Food and Drug Administration (FDA) announced that the United States is experiencing interruptions in the supply of prefilled 0.9% sodium chloride (saline) IV lock/flush syringes because of an increase in demand during the COVID-19 pandemic and vendor supply chain challenges, including the permanent discontinuance of certain prefilled saline lock/flush syringes.

On March 21, 2022, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) as a single agent for patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) advanced endometrial carcinoma, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation.

On March 18, 2022, the U.S. Food and Drug Administration (FDA) approved nivolumab and relatlimab-rmbw (Opdualag™) for adult and pediatric patients aged 12 years or older with unresectable or metastatic melanoma. Nivolumab and relatlimab-rmbw is a fixed-dose combination of the LAG-3–blocking antibody relatlimab and the programmed death receptor-1–blocking antibody nivolumab.

On March 11, 2022, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza^®) for adult patients with deleterious or suspected deleterious germline BRCA variant (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients are selected for therapy based on an FDA-approved companion diagnostic for olaparib.

On February 28, 2022, the U.S. Food and Drug Administration (FDA) approved ciltacabtagene autoleucel (Carvykti™) for adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. Ciltacabtagene autoleucel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy.

On March 4, 2022, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo^®) with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting, representing the first FDA approval for neoadjuvant therapy for early-stage NSCLC.

On March 3, 2022, the U.S. Food and Drug Administration (FDA) reported B. Braun Medical’s voluntary recall of five lots of 0.9% sodium chloride for injection USP 250 ml in Excel within the United States at the hospital and user levels after receiving reports of fluid leakage or low fill volumes.

On February 18, 2022, the U.S. Food and Drug Administration (FDA) reported Baxter International’s urgent safety communication to reinforce safety information regarding upstream occlusion alarms for all Spectrum V8 and Spectrum IQ infusion pumps.

Balancing the benefits of e-cigarettes for adults with the harms makes regulating e-cigarette marketing particularly challenging, U.S. Food and Drug Administration (FDA) Center for Tobacco Products Director Mitch Zeller, JD, said in a January 2022 interview with the National Cancer Institute (NCI). FDA continuously evaluates e-cigarettes and tobacco companies’ marketing strategies, and Zeller says it’s up to tobacco companies to make those differences clear in their advertising.