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In early 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to a new Alzheimer’s drug called Leqembi. (Biogen, a biotechnology company, and Eisai, a pharmaceutical ...
In the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo the FDA's approval process. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical condition. Drug companies seeking to sell a drug in the United States must ...
The drug had been expected to be approved last year, but that was delayed as the FDA sought more information about repeat dosing. The agency said Friday that patients may need to seek emergency ...
The FDA has approved a new drug for some adult patients with endometrial cancer. Jemperli (dostarlimably) — made by U.K. company GSK — is intended for primary advanced or recurrent disease.
This is a list of progestogens (progesterone and progestins) and formulations that are approved by the FDA Tooltip Food and Drug Administration in the United States. Progestogens are used as hormonal contraceptives, in hormone replacement therapy for menopausal symptoms, and in the treatment of gynecological disorders.
Avelumab is FDA approved for the treatment of metastatic merkel-cell carcinoma. It failed phase III clinical trials for gastric cancer. Durvalumab (Imfinzi) is a fully human IgG1 antibody developed by AstraZeneca. Durvalumab is FDA approved for the treatment of urothelial carcinoma and unresectable non-small cell lung cancer after chemoradiation.
The FDA's latest approval was based on a late-stage trial where Fabhalta showed a 43.8% reduction in proteinuria when compared to placebo. Proteinuria is excess protein in the urine and can be a ...
Capmatinib was approved for medical use in the United States in May 2020. [7] [8] Capmatinib is the first therapy approved by the US Food and Drug Administration (FDA) to treat non-small cell lung cancer with specific mutations (those that lead to mesenchymal-epithelial transition or MET exon 14 skipping). [4]