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Lenacapavir was approved for medical treatment in the European Union in August 2022, [10] [12] in Canada in November 2022, [5] [6] and in the United States in December 2022. [9] [11] [13] [14] It is the first of a class of drugs called capsid inhibitors to be approved by the US Food and Drug Administration (FDA) for treating HIV/AIDS. [11] [15]
Gilead's Sunlenca, whose common name is lenacapavir, is given once every six months as an injection, but will be in addition to the current treatment regimen of patients. U.S. FDA approves Gilead ...
Lenacapavir, branded as Sunlenca, gained U.S. approval in 2022 as a treatment for heavily pre-treated HIV patients. Baeten said that lenacapavir could be approved for PrEP by the end of next year.
In 2022, the capsid inhibitor Lenacapavir received approval from the European Medicines Agency, Health Canada, and the United States Food and Drug Administration as a first-in-class medication to treat HIV-1 infection.
The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form.
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Thalidomide — withdrawn in 1961 owing to widespread incidence of severe birth defects (phocomelia or tetraamelia) after prenatal use by pregnant women, US Food and Drug Administration approved thalidomide for erythema nodosum leprosum (ENL) in 1998, and 2008 for new cases of multiple myeloma (administered with dexamethasone). A large "off ...
A new opioid-free pain medication was approved by the U.S. Food and Drug Administration (FDA) on Thursday, marking a non-addictive alternative for patients. Journavx (suzetrigine), made by Vertex ...