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Bristol Myers Squibb announced the commercial US launch of ozanimod (Zeposia) for the treatment of relapsing forms of multiple sclerosis.
Officials with the FDA approved atezolizumab (Tecentriq, Genentech) in combination with bevacizumab (Avastin) for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
Officials with the FDA have granted priority review for mepolizumab (Nucala, GlaxoSmithKline) in the treatment of patients with hypereosinophilic syndrome.
Dupilumab (Dupixent, Sanofi and Regeneron) is the first biologic medicine approved for treatment of moderate-to-severe atopic dermatitis.
Fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) is indicated for treating adults with unresectable or metastatic HER2-positive breast cancer who have received 2 or more prior anti-HER2–based regimens in the setting of metastasis.
Officials with the FDA granted Emergency Use Authorization (EUA) to the first diagnostic test that will allow at-home collection of saliva samples for coronavirus disease 2019 (COVID-19) testing.
Officials with the FDA have approved celecoxib oral solution 25 mg/mL (Elyxyb, Dr. Reddy’s Laboratories) for the acute treatment of migraine with or without aura in adults.
Officials with the FDA have approved dapagliflozin (Farxiga, AstraZeneca) to reduce the risk of cardiovascular death and hospitalization in adults with heart failure with reduced ejection fraction, with and without type 2 diabetes.
Rituximab-abbs (Truxima) is the only biosimilar to the reference product rituximab (Rituxan).
Officials with the FDA have granted accelerated approval to sacituzumab govitecan-hziy (Trodelvy, Immunomedics Inc.) for previously-treated adult patients with metastatic triple-negative breast cancer.
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