FDA New Approvals
The FDA has approved Byooviz (ranibizumab-nuna), a biosimilar referencing Lucentis (ranibizumab), for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.
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The FDA has approved Livmarli (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with Alagille syndrome who are aged one year or older. Livmarli is a minimally absorbed ileal bile acid transporter inhibitor and is the first FDA-approved medication in this liver disease.
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The FDA has approved Opzelura (ruxolitinib) cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients aged 12 years and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Opzelura is the first and only topical formulation of a JAK inhibitor approved in the US.
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The FDA has approved Qulipta (atogepant) for the preventive treatment of episodic migraine in adults. Qulipta is the first and only oral calcitonin gene-related peptide receptor antagonist specifically developed for the preventive treatment of migraine.
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FDA New Indications
The FDA has approved Jakafi (ruxolitinib) for treatment of chronic graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older. This is the fourth FDA-approved indication for Jakafi, which received FDA approval in 2019 for steroid-refractory acute GVHD in adult and pediatric patients aged 12 years and older.
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The FDA has approved Repatha (evolocumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C)-lowering therapies for the treatment of pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia to reduce LDL-C.
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The FDA has approved Tecartus (brexucabtagene autoleucel) for the treatment of adult patients (aged 18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
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The FDA has approved Tivdak (tisotumab vedotin-tftv), the first and only approved antibody-drug conjugate for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
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Bayer Lotrimin AF and Tinactin
Bayer is voluntarily recalling all unexpired Lotrimin AF and Tinactin spray products with lot numbers beginning with TN, CV, or NAA, distributed between September 2018 to September 2021, to the consumer level due to the presence of benzene in some samples of the products.
Learn more about the Bayer Lotrimin AF and Tinactin recall
Coppertone Aerosol Sunscreen
Coppertone, owned by Beiersdorf, is voluntarily recalling specific lots of five Coppertone aerosol sunscreen spray products manufactured between January 10, 2021 and June 15, 2021, to the consumer level. Coppertone has identified the presence of benzene in these lots of products. Twelve lots of Coppertone spray products are impacted by this voluntary recall.
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Eli Lilly Glucagon Emergency Kit
Eli Lilly and Company is voluntarily recalling lot D239382D, expiration April 2022, of glucagon emergency kit for low blood sugar (glucagon for injection, 1mg per vial; diluent for glucagon, 1mL syringe), to the consumer/user level. Lilly is recalling lot D239382D to the patient level because of a product complaint reporting that the vial of glucagon was in liquid form instead of the powder form.
Learn more about the Eli Lilly glucagon emergency kit recall
IntegraDose Compounding Services Cefazolin
IntegraDose Compounding Services is voluntarily recalling nine lots of cefazolin 2g in 20mL syringe for injection and two lots of cefazolin 3g 100mL 0.9% sodium chloride bag for injection due to a lack of sterility assurance resulting from compounding in a newly installed biologic safety cabinet without completing dynamic smoke study testing.
Learn more about the IntegraDose Compounding Services cefazolin recall