Skip to main content
Search
News, Views, and Advocacy From the Oncology Nursing Society
ONS Voice Home
  • News & Views
  • Advocacy
  • Stories
  • Instagram
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • RSS
  • News & Views
    • Latest Articles
    • Clinical Practice
    • ONS News
    • ONS Leadership
    Trending Topics
    • Research
    • Treatments
    • Safety
    • COVID-19
    • Drug Reference Sheet
    • Special Populations
    View All Topics
    Advocacy
    • Latest Articles
    • Updates
    • Get Involved
    Stories View All
    View All
    Clinical and Pharmaceutical Nurse Educators Collaborate to Bring Training to Nurses and Improve Patient Care
    Oncology nurse education
    Clinical and Pharmaceutical Nurse Educators Collaborate to Bring Training to Nurses and Improve Patient Care
    January 13, 2023
    Oncology Nurse Uses Retirement to Help Patients and Healthcare Professionals Understand Pancreatic Cancer Biomarker Testing Results
    Pancreatic cancer
    Oncology Nurse Uses Retirement to Help Patients and Healthcare Professionals Understand Pancreatic Cancer Biomarker Testing Results
    November 11, 2022
    The Life of Marie Curie and Her Contributions to Oncology
    Cancer treatments
    The Life of Marie Curie and Her Contributions to Oncology
    November 07, 2022
    Post-Flooding Natural Disaster Cancer Considerations and Patient Education Points
    Patient safety
    Post-Flooding Natural Disaster Cancer Considerations and Patient Education Points
    September 28, 2022
    Can Patients Use Continuous Glucose Monitors During Radiation Therapy for Cancer?
    Radiation therapy
    Can Patients Use Continuous Glucose Monitors During Radiation Therapy for Cancer?
    August 19, 2022
    previous slide
    next slide
    Search
  • News & Views
  • Advocacy
  • Stories
  • Topic

    U.S. Food and Drug Administration (FDA)

    Oncology Drug Reference Sheet: Darolutamide
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Darolutamide

    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.

    January 26, 2023
    FDA Approves Zanubrutinib for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Zanubrutinib for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

    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.

    January 20, 2023
    FDA Grants Accelerated Approval to Tucatinib With Trastuzumab for Colorectal Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Tucatinib With Trastuzumab for Colorectal Cancer

    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.

    January 20, 2023
    Smiths Medical Issues Urgent Medical Device Correction Letter About Potential Issues With CADD™ Infusion Sets
    U.S. Food and Drug Administration (FDA)

    Smiths Medical Issues Urgent Medical Device Correction Letter About Potential Issues With CADD™ Infusion Sets

    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.

    January 12, 2023
    Spectrum Laboratory Products, Inc., Issues Voluntary Recall of Epinephrine USP, Bulk API, Because of Product Discoloration
    U.S. Food and Drug Administration (FDA)

    Spectrum Laboratory Products, Inc., Issues Voluntary Recall of Epinephrine USP, Bulk API, Because of Product Discoloration

    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.

    January 12, 2023
    FDA Grants Accelerated Approval to Mosunetuzumab-Axgb for Relapsed or Refractory Follicular Lymphoma
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Mosunetuzumab-Axgb for Relapsed or Refractory Follicular Lymphoma

    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.

    January 06, 2023
    Hospira, Inc., Issues Voluntary Nationwide Recall for One Lot of Vancomycin Hydrochloride Injection, USP 1.5 g
    U.S. Food and Drug Administration (FDA)

    Hospira, Inc., Issues Voluntary Nationwide Recall for One Lot of Vancomycin Hydrochloride Injection, USP 1.5 g

    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.

    January 04, 2023
    Accord Healthcare, Inc., Issues Voluntary Recall for Lot of Daptomycin for Injection
    U.S. Food and Drug Administration (FDA)

    Accord Healthcare, Inc., Issues Voluntary Recall for Lot of Daptomycin for Injection

    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.”

    January 04, 2023
    FDA Approves First Adenoviral Vector-Based Gene Therapy for High-Risk, BCG Unresponsive, Non–Muscle-Invasive Bladder Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves First Adenoviral Vector-Based Gene Therapy for High-Risk, BCG Unresponsive, Non–Muscle-Invasive Bladder Cancer

    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.

    December 22, 2022
    FDA Approves Updated Drug Labeling Including New Indications and Dosing Regimens for Capecitabine Tablets Under Project Renewal
    U.S. Food and Drug Administration (FDA)

    FDA Approves Updated Drug Labeling Including New Indications and Dosing Regimens for Capecitabine Tablets Under Project Renewal

    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.

    December 16, 2022
    FDA Grants Accelerated Approval to Adagrasib for KRAS G12C–Variant Non-Small Cell Lung Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Adagrasib for KRAS G12C–Variant Non-Small Cell Lung Cancer

    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.

    December 14, 2022
    FDA Approves Atezolizumab for Alveolar Soft Part Sarcoma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Atezolizumab for Alveolar Soft Part Sarcoma

    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.

     

    December 13, 2022
    FDA Approves Olutasidenib for Relapsed or Refractory Acute Myeloid Leukemia With Susceptible IDH1 Variants
    U.S. Food and Drug Administration (FDA)

    FDA Approves Olutasidenib for Relapsed or Refractory Acute Myeloid Leukemia With Susceptible IDH1 Variants

    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.

    December 05, 2022
    FDA Approves Second Dosing Regimen for Asparaginase Erwinia Chrysanthemi (Recombinant)-Rywn
    U.S. Food and Drug Administration (FDA)

    FDA Approves Second Dosing Regimen for Asparaginase Erwinia Chrysanthemi (Recombinant)-Rywn

    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.

    November 22, 2022
    FDA Approves Brentuximab Vedotin in Combination With Chemotherapy for Pediatric Patients With Classical Hodgkin Lymphoma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Brentuximab Vedotin in Combination With Chemotherapy for Pediatric Patients With Classical Hodgkin Lymphoma

    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.

    November 16, 2022
    FDA Grants Accelerated Approval to Mirvetuximab Soravtansine-Gynx for FR Alpha–Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Mirvetuximab Soravtansine-Gynx for FR Alpha–Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

    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.

    November 16, 2022
    FDA and DOJ File Permanent Injunctions Against Six E-Cigarette Manufacturers
    U.S. Food and Drug Administration (FDA)

    FDA and DOJ File Permanent Injunctions Against Six E-Cigarette Manufacturers

    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.

    November 16, 2022
    FDA Removes Racist Root From Tobacco Database Terminology
    U.S. Food and Drug Administration (FDA)

    FDA Removes Racist Root From Tobacco Database Terminology

    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.

    November 14, 2022
    FDA Approves Tremelimumab in Combination With Durvalumab and Platinum-Based Chemotherapy for Metastatic Non-Small Cell Lung Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Tremelimumab in Combination With Durvalumab and Platinum-Based Chemotherapy for Metastatic Non-Small Cell Lung Cancer

    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.

    November 11, 2022
    FDA Recommends Reusing Tracheostomy Tubes or Switching to Appropriate Alternatives Because of Shortage
    U.S. Food and Drug Administration (FDA)

    FDA Recommends Reusing Tracheostomy Tubes or Switching to Appropriate Alternatives Because of Shortage

    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.

    November 02, 2022
    FDA Recommends Healthcare Providers Consider Alternatives for MRI-Guided Breast Biopsy Grid Plates Because of Shortage
    U.S. Food and Drug Administration (FDA)

    FDA Recommends Healthcare Providers Consider Alternatives for MRI-Guided Breast Biopsy Grid Plates Because of Shortage

    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. 

    November 02, 2022
    New Data Show 2.5 Million Youth Currently Use E-Cigarettes
    U.S. Food and Drug Administration (FDA)

    New Data Show 2.5 Million Youth Currently Use E-Cigarettes

    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.

    October 31, 2022
    FDA Approves Teclistamab-Cqyv for Relapsed or Refractory Multiple Myeloma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Teclistamab-Cqyv for Relapsed or Refractory Multiple Myeloma

    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.

     

    October 26, 2022
    FDA Approves Tremelimumab in Combination With Durvalumab for Unresectable Hepatocellular Carcinoma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Tremelimumab in Combination With Durvalumab for Unresectable Hepatocellular Carcinoma

    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.

    October 25, 2022
    Exela Pharma Sciences, LLC, Issues Voluntary Nationwide Recall of Sodium Bicarbonate Injection Because of Vial Breakage
    U.S. Food and Drug Administration (FDA)

    Exela Pharma Sciences, LLC, Issues Voluntary Nationwide Recall of Sodium Bicarbonate Injection Because of Vial Breakage

    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.

    October 14, 2022
    Eugia US, LLC, Recalls AuroMedics Acyclovir Sodium Injection Because of Particulate Matter
    U.S. Food and Drug Administration (FDA)

    Eugia US, LLC, Recalls AuroMedics Acyclovir Sodium Injection Because of Particulate Matter

    On September 27, 2022, the U.S. Food and Drug Administration reported Eugia US, LLC’s, voluntary recall of AuroMedics acyclovir sodium injection 500 mg per 10 ml (50 mg/ml) single-dose vial to the consumer level because of reported presence of a dark red, brown, and black particulate inside the vial.

    October 03, 2022
    FDA Grants Accelerated Approval to Futibatinib for Cholangiocarcinoma
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Futibatinib for Cholangiocarcinoma

    On September 30, 2022, the U.S. Food and Drug Administration granted accelerated approval to futibatinib (Lytgobi®) for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangements.

    October 03, 2022
    FDA Issues New Guidance to Help Facilitate Availability of Naloxone to Prevent Opioid Overdoses and Reduce Death
    U.S. Food and Drug Administration (FDA)

    FDA Issues New Guidance to Help Facilitate Availability of Naloxone to Prevent Opioid Overdoses and Reduce Death

    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.

    September 27, 2022
    FDA Approves Selpercatinib for RET Fusion-Positive Non-Small Cell Lung Cancer and Locally Advanced or Metastatic Solid Tumors
    U.S. Food and Drug Administration (FDA)

    FDA Approves Selpercatinib for RET Fusion-Positive Non-Small Cell Lung Cancer and Locally Advanced or Metastatic Solid Tumors

    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.

    September 23, 2022
    FDA Approves Sodium Thiosulfate for Cisplatin-Associated Ototoxicity n Pediatric Patients
    U.S. Food and Drug Administration (FDA)

    FDA Approves Sodium Thiosulfate for Cisplatin-Associated Ototoxicity in Pediatric Patients

    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.

    September 22, 2022
    Baxter Healthcare Corporation Recalls Clearlink Basic Solution Set With Duovent Because of Leaks That Risk Exposure to Toxic Substances
    U.S. Food and Drug Administration (FDA)

    Baxter Healthcare Corporation Recalls Clearlink Basic Solution Set With Duovent Because of Leaks That Risk Exposure to Toxic Substances

    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.

    September 16, 2022
    FDA Reports Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Breast Implants
    U.S. Food and Drug Administration (FDA)

    FDA Reports Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Breast Implants

    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.

    September 12, 2022
    FDA Approves Durvalumab for Locally Advanced or Metastatic Biliary Tract Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Durvalumab for Locally Advanced or Metastatic Biliary Tract Cancer

    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.

    September 07, 2022
    FDA Approves Pemigatinib for Relapsed or Refractory Myeloid or Lymphoid Neoplasms With FGFR1 Rearrangement
    U.S. Food and Drug Administration (FDA)

    FDA Approves Pemigatinib for Relapsed or Refractory Myeloid or Lymphoid Neoplasms With FGFR1 Rearrangement

    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.

    August 30, 2022
    Intera Oncology Recalls Intera 3000 Hepatic Artery Infusion Pump Because of Faster-Than-Expected Flow Rates
    U.S. Food and Drug Administration (FDA)

    Intera Oncology Recalls Intera 3000 Hepatic Artery Infusion Pump Because of Faster-Than-Expected Flow Rates

    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.

    August 30, 2022
    FDA Approves Ibrutinib for Pediatric Patients With Chronic Graft-Versus-Host Disease, Including a New Oral Suspension
    U.S. Food and Drug Administration (FDA)

    FDA Approves Ibrutinib for Pediatric Patients With Chronic Graft-Versus-Host Disease, Including a New Oral Suspension

    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.

    August 25, 2022
    Truth Initiative Asks for Removal of Unauthorized E-Cigarettes
    U.S. Food and Drug Administration (FDA)

    Truth Initiative Asks for Removal of Unauthorized E-Cigarettes

    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.

    August 23, 2022
    FDA Grants Accelerated Approval to Fam-Trastuzumab Deruxtecan-Nxki for HER2-Variant Non-Small Cell Lung Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Fam-Trastuzumab Deruxtecan-Nxki for HER2-Variant Non-Small Cell Lung Cancer

    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.

    August 15, 2022
    FDA Approves Capmatinib for Metastatic Non-Small Cell Lung Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Capmatinib for Metastatic Non-Small Cell Lung Cancer

    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.

    August 15, 2022
    FDA Publishes Three New Biosimilars Resources for Healthcare Providers
    U.S. Food and Drug Administration (FDA)

    FDA Publishes Three New Biosimilars Resources for Healthcare Providers

    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.

    August 11, 2022
    FDA Won’t Finish Reviewing E-Cigarette Marketing Applications Until June 2023
    Cancer risk prevention

    FDA Won’t Finish Reviewing E-Cigarette Marketing Applications Until June 2023

    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.

    August 09, 2022
    FDA Approves Darolutamide Tablets for Metastatic Hormone-Sensitive Prostate Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Darolutamide Tablets for Metastatic Hormone-Sensitive Prostate Cancer

    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.

    August 08, 2022
    FDA Approves Fam-Trastuzumab Deruxtecan-Nxki for HER2-Low Breast Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Fam-Trastuzumab Deruxtecan-Nxki for HER2-Low Breast 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.

    August 08, 2022
    FDA Reports Recall of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination
    U.S. Food and Drug Administration (FDA)

    FDA Reports Recall of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination

    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.

    July 28, 2022
    Baxter Healthcare Corporation Recalls Abacus Software for Risk of Medication Label Errors
    U.S. Food and Drug Administration (FDA)

    Baxter Healthcare Corporation Recalls Abacus Software for Risk of Medication Label Errors

    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.

    July 26, 2022
    The action against JUUL Labs Inc. is part of initial efforts to minimize the harm of tobacco and vapes on the public. This order comes after FDA announced two proposals prohibiting menthol in cigarettes and characterizing flavors in cigars in April 2022.   Smoking and vaping cessation efforts have long been a priority for ONS. At least a dozen of cancers can be tied back to tobacco use, making advocating for regulations and cessation crucial for preventative care.
    U.S. Food and Drug Administration (FDA)

    FDA Orders JUUL to Stop Selling All of Its Products

    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.

    July 25, 2022
    Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Infusion Pumps for Software Malfunctions That Can Affect Infusion Delivery
    U.S. Food and Drug Administration (FDA)

    Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Infusion Pumps for Software Malfunctions That Can Affect Infusion Delivery

    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.

    July 21, 2022
    FDA Approves Crizotinib for Anaplastic Lymphoma Kinase-Positive Inflammatory Myofibroblastic Tumor
    U.S. Food and Drug Administration (FDA)

    FDA Approves Crizotinib for Anaplastic Lymphoma Kinase-Positive Inflammatory Myofibroblastic Tumor

    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).

    July 15, 2022
    FDA Launches Campaign to Prevent Vaping Use Among American Indian and Alaska Native Youth
    Cancer risk prevention

    FDA Launches Campaign to Prevent Vaping Use Among American Indian and Alaska Native Youth

    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.

    July 13, 2022
    Legislation Funds FDA Programs to Support Safety, Lower Costs, and Spur Innovation
    Prescription medication

    Legislation Funds FDA Programs to Support Safety, Lower Costs, and Spur Innovation

    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.

    July 11, 2022
    • Current page 1
    • Page 2
    • Page 3
    • Page 4
    • Page 5
    • Page 6
    • Page 7
    • Page 8
    • Page 9
    • …
    • Next page
    • Last page Last »
    Trending Topics
    • Research
    • Treatments
    • Safety
    • COVID-19
    • Drug Reference Sheet
    • Special Populations
    • Clinical practice
    • U.S. Food and Drug Administration (FDA)
    • Health Policy
    • Immunotherapy
    View All Topics
     
    Home
    News, Views, and Advocacy From the Oncology Nursing Society
  • Legal Notices
  • Contact Us
  • Conferences
  • Advertising
  • Newsroom
  • Sitemap
  • Instagram
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • RSS
  • ONS
  • Oncology Nursing Foundation
  • ONCC
  • © Copyright 2023 Oncology Nursing Society
     
    Back to Top ▲