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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]
U.S. FDA approves Gilead's long-acting HIV drug Sunlenca December 22, 2022 at 11:26 AM FILE PHOTO: The logo of Gilead Sciences Inc pharmaceutical company is seen in Oceanside, California
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.
(not approved) (many companies) Yes Generics, e.g., Duovir-N: lamivudine zidovudine: nevirapine (not approved) (many companies) Yes Truvada: emtricitabine tenofovir disoproxil: August 2, 2004 Gilead Sciences: No Atripla: emtricitabine tenofovir disoproxil efavirenz: July 12, 2006 Gilead Sciences Bristol-Myers Squibb: Yes Complera (US) Eviplera ...
Elon Musk’s Department of Government Efficiency has a new target to cut down costs: the US penny.
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.
SOURCE: Integrated Postsecondary Education Data System, University of North Carolina at Asheville (2014, 2013, 2012, 2011, 2010).Read our methodology here.. HuffPost and The Chronicle examined 201 public D-I schools from 2010-2014.