FDA New Approvals
The FDA has approved Kimmtrak (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. Kimmtrak is the first therapy to demonstrate a survival benefit to patients with this disease.
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The FDA has approved Vabysmo (faricimab-svoa) for the treatment of wet, or neovascular, age-related macular degeneration and diabetic macular edema.
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The FDA has approved Vocabria (cabotegravir) in combination with Edurant (rilpivirine) for short-term treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine, for use as: oral lead-in to assess the tolerability of cabotegravir prior to administration of Cabenuva (cabotegravir; rilpivirine) extended-release injectable suspensions; oral therapy for patients who will miss planned injection dosing with Cabenuva.
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FDA First-Time Generic Approvals
The FDA has approved the first generic of Restasis (cyclosporine) ophthalmic emulsion 0.05% single-use vials to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
Learn more about Restasis
FDA Labeling Changes
The FDA has approved an update to the prescribing information for Yescarta (axicabtagene ciloleucel) to include use of prophylactic corticosteroids across all approved indications. Yescarta is now the first and only chimeric antigen receptor T-cell therapy with information in the label to help physicians manage, and potentially prevent, treatment side effects.
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FDA New Indications
The FDA has approved Cabenuva (rilpivirine and cabotegravir) as a 2-drug co-packaged product to be administered every two months for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either rilpivirine or cabotegravir. Cabenuva is administered by a healthcare provider as two intramuscular injections (rilpivirine and cabotegravir) in the buttocks.
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The FDA has approved Skyrizi (risankizumab-rzaa) for the treatment of adults with active psoriatic arthritis.
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The FDA has approved Veklury (remdesivir) for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, including hospitalization or death. The expanded indication allows for Veklury to be administered in qualified outpatient settings that can administer daily intravenous infusions over three consecutive days. The FDA has also expanded the pediatric Emergency Use Authorization of Veklury to include non-hospitalized pediatric patients younger than 12 years who are at high risk of disease progression.
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The FDA has approved Vonvendi (von Willebrand factor [recombinant]) for routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 von Willebrand disease receiving on-demand therapy.
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FDA New Dosing
The FDA has approved a 40mg prefilled syringe of Nucala (mepolizumab) for appropriate children aged 6 to 11 years who have severe eosinophilic asthma. Nucala can now be given by a child’s healthcare provider or administered at home by a caregiver once trained by a healthcare professional. Nucala is an add-on prescription maintenance treatment for patients aged 6 years and older with severe eosinophilic asthma.
Learn more about Nucala
Auromedics Polymyxin B
Auromedics has initiated a voluntary recall of lot number CPB200013 of polymyxin B for injection USP, 500,000 units/vial, to the consumer level due to a product complaint about the presence of particulate matter, identified as hair, being discovered in a vial within this lot.
Learn more about the Auromedics polymyxin B recall
Blaine Labs Company Wound Care Gel
Blaine Labs Company is voluntarily recalling one lot of RevitaDerm Wound
Care to the consumer level because a bottle of the 1.0-oz RevitaDerm Wound Care
Gel has been found to be contaminated with Bacillus cereus.
Learn more about the Blaine Labs Company wound care gel recall
Esupplementsales Hard Dawn Rise and Shine
Esupplementsales is voluntarily recalling lot number 2107 of Hard Dawn Rise and Shine capsules to the consumer level. Esupplementsales was informed by Amazon that laboratory analysis found the product to be tainted with tadalafil. The presence of tadalafil in Hard Dawn Rise and Shine capsules renders the product an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Learn more about the Esupplementsales Hard Dawn Rise and Shine recall
The FDA is investigating a possible increased risk of death with the cancer medicine Ukoniq (umbralisib) approved to treat two specific types of lymphomas. The FDA determined that initial findings from a clinical trial evaluating Ukoniq to treat a related type of cancer found a possible increased risk of death in patients taking the medicine. Because of the seriousness of this safety concern and the similarities between the two types of cancer for which this drug is approved and the type of cancer that was studied in the clinical trial, the FDA is alerting patients and healthcare professionals that Ukoniq is being reevaluated for the risk against the benefits of for its approved uses.
Learn more about the Ukoniq alert