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The FDA granted the approval of Jatenzo to Clarus Therapeutics. [22] [51] In March 2022, testosterone undecanoate (Tlando) was approved for medical use in the United States. [5] In July 2022, Kyzatrex, an oral testosterone undecanoate capsule, was approved for medical use in the United States.
Drugs granted breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA). Drugs may be listed more than once since breakthrough therapy can be awarded for multiple indications.
Geroscience has a long way to go, but there are four FDA-approved drugs that have shown promise to “target the process of aging,” Barzilai says. While not approved as anti-aging treatments ...
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 ...
Abemaciclib was approved for the adjuvant treatment of HR+, HER2-, node-positive adjuvant breast cancer at high risk of recurrence in March 2023. [15] [16] As of 2023, abemaciclib was involved in two Phase III clinical trials: The SARC041 study compares abemaciclib versus placebo in patients with advanced dedifferentiated liposarcoma. [17]
With standard FDA approval, Medicare has said it will reimburse patients for the treatment as long as their doctors collect data and submit it to a free health agency database, known as a registry
It is a microtubule inhibitor, [2] and the fourth taxane to be approved as a cancer therapy. [citation needed] Cabazitaxel was developed by Sanofi-Aventis and was approved by the US Food and Drug Administration (FDA) for the treatment of hormone-refractory prostate cancer in June 2010. [5] [6] [7] It is available as a generic medication. [8] [9]
Risankizumab was approved by the U.S. Food and Drug Administration (FDA) for treatment of moderate-to-severe plaque psoriasis in April 2019. [13] [10] [14]The FDA approved risankizumab based on evidence primarily from five clinical trials (Trial 1/NCT02684370, Trial 2/NCT02684357, Trial 3/NCT02672852, Trial 4/ NCT02694523, and Trial 5/NCT02054481) of 1606 participants with moderate to severe ...