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  • FDA Drug Updates

    FDA New Approvals


    The FDA has approved Elahere (mirvetuximab soravtansine-gynx) for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Elahere is a first-in-class antibody-drug conjugate (ADC) directed against FRα, a cell-surface protein highly expressed in ovarian cancer, and is the first FDA-approved ADC for platinum-resistant disease. Learn more about Elahere


    The FDA has approved Hemgenix (etranacogene dezaparvovec-drlb), the first and only one-time gene therapy for appropriate adults with hemophilia B. Hemgenix is approved for the treatment of adults with hemophilia B who currently use factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage or have repeated, serious spontaneous bleeding episodes. Learn more about Hemgenix


    The FDA has approved Rebyota (fecal microbiota, live-jslm), a novel first-in-class microbiota-based live biotherapeutic indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals aged 18 years and older, following antibiotic treatment for recurrent CDI. Learn more about Rebyota


    The FDA has approved Rezlidhia (olutasidenib) capsules for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. Rezlidhia is an oral, small molecule, inhibitor of mutated IDH1 designed to bind to and inhibit mIDH1 to reduce 2-hydroxyglutarate levels and restore normal cellular differentiation of myeloid cells. Learn more Rezlidhia


    The FDA has approved Rezvoglar (insulin glargine-aglr) as the second interchangeable biosimilar insulin product to Lantus (insulin glargine). Rezvoglar is a long-acting human insulin analogue indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Learn more about Rezvoglar


    The FDA has approved Sezaby (phenobarbital sodium) powder for injection for the treatment of neonatal seizures. With this approval, Sezaby becomes the first and only product specifically indicated in the US for the treatment of neonatal seizures in term and preterm infants. Sezaby is expected to be available in the fourth quarter of 2023. Learn more about Sezaby


    The FDA has approved Tzield (teplizumab-mzwv), an anti-CD3-directed antibody, for intravenous use, as the first and only immunomodulatory treatment to delay the onset of stage 3 type 1 diabetes in adult and pediatric patients aged 8 years and older with stage 2 type 1 diabetes. Learn more about Tzield

    FDA New Indications


    The FDA has approved Adcetris (brentuximab vedotin) for the treatment of pediatric patients aged 2 years and older with previously untreated high-risk classical Hodgkin lymphoma, in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide. Learn more about Adcetris


    The FDA has approved a second indication for Brexafemme (ibrexafungerp) tablets for the reduction in the incidence of recurrent vulvovaginal candidiasis. Brexafemme represents the first approved drug in a new antifungal class in over 20 years and is the first and only treatment for vaginal yeast infections that is both oral and non-azole. Learn more about Brexafemme

    Imfinzi with Imjudo

    The FDA has approved Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) plus platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer. Learn more about Imfinzi with Imjudo


    The FDA has approved Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer with no EGFR, ALK, or ROS1 aberrations. Patients must either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation. Patients may be treated with this combination irrespective of PD-L1 expression or histology. Learn more about Libtayo


    The FDA has approved extended duration of use of Liletta (levonorgestrel-releasing intrauterine system) 52mg to prevent pregnancy for up to eight years. With this FDA approval, Liletta has one of the longest approved durations of use for a hormonal intrauterine device in the US. Learn more about Liletta

    FDA New Dosing


    The FDA has approved a new Monday/Wednesday/Friday intramuscular dosing schedule for Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn). Rylaze is approved for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients one month or older who have developed hypersensitivity to E. coli-derived asparaginase. Learn more about Rylaze

    FDA Recalls

    Adam’s Polishes Hand Sanitizer

    Adam’s Polishes, LLC is voluntarily recalling lot 133475 of Adam’s Polishes Hand Sanitizer, to the consumer level. FDA testing has found this lot to contain undeclared methanol. Adam’s Polishes is recalling 19 other lots in an abundance of caution. Learn more about the Adam’s Polishes Hand Sanitizer recall

    Exela Pharma Sodium Bicarbonate

    Exela Pharma Sciences, LLC is expanding their recall, adding fourteen lots to the ongoing voluntary recall of forty-nine lots of sodium bicarbonate injection, USP, 8.4%, 50mEq/50mL vial, 20-count carton. A total of 63 lots are now being recalled to the consumer level. Learn more about the Exela Pharma sodium bicarbonate recall

    FDA Alerts

    Luer-Activated Valve Connectors Compatibility Issues

    The FDA is alerting healthcare professionals that certain Luer-activated valve (LAV) connectors (sometimes referred to as needleless Luer access devices or needleless connectors) with internal pin designs may not be compatible with prefilled glass syringes. The internal pin of the LAV connector may break when attached to a prefilled glass syringe, causing the LAV connector to clog and prevent administration of the drug. Incompatibility, particularly in emergency and urgent situations, can delay therapy and potentially result in serious harm to patients. Learn more about Luer-activated valve connectors compatibility issues

    Severe Hypocalcemia Risk with Prolia

    The FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab). Review of interim results from an ongoing safety study of Prolia suggests an increased risk of hypocalcemia, or low calcium levels in the blood, in patients with advanced kidney disease. Preliminary results from a separate internal FDA study further investigating hypocalcemia in dialysis patients treated with Prolia show a substantial risk with serious outcomes, including hospitalization and death. Learn more about severe hypocalcemia risk with Prolia

    Xylazine in Illicit Drugs

    Healthcare professionals should be cautious of possible xylazine inclusion in fentanyl, heroin, and other illicit drug overdoses, as naloxone may not be able to reverse its effects. The FDA is aware of increasing reports of serious side effects from individuals exposed to fentanyl, heroin, and other illicit drugs contaminated with xylazine. Learn more about xylazine in illicit drugs