FDA Archives - Lupus Research

Tag: FDA

Over Half of People with Lupus Would Take COVID-19 Vaccine, Shows LRA Survey

Updated January 4, 2021 New York, NY– December 16, 2020. More than half of people with lupus (54%) are willing to take a COVID-19 vaccine if it is free and determined safe by scientists according to results of a survey conducted by the Lupus Research Alliance (LRA). However, it is important to note that 24% […] Read More

Lupus Research Alliance Hails Approval of Aurinia’s Lupkynis(TM) (voclosoporin)

First Oral Treatment for Lupus Nephritis; Second Lupus Treatment to Receive FDA Approval in Past Month NEW YORK, NY. January 22, 2021. The Lupus Research Alliance (LRA) is excited to share that the U.S. Food and Drug Administration (FDA) approved the use of Aurinia Pharmaceuticals’ LupkynisTM (voclosporin) as the first oral treatment developed specifically for […] Read More

You Spoke and Congress Acted

March 15, 2022 Each year, Congress must allocate funds for the following year’s budget, and every year, we lead the advocacy effort for the additional funding needed for lupus research to produce better treatments and eliminate racial disparities in healthcare. Last March lupus advocates joined the LRA to submit formal Congressional Asks for Fiscal Year […] Read More

LRA Writes President Supporting Dr. Janet Woodcock for FDA Commissioner

March 31, 2021 As part of the LRA’s mission to accelerate development and availability of much-needed new diagnostics and treatments for lupus, the organization’s President and CEO, Mr. Kenneth M. Farber, submitted a letter to President Joseph Biden to express LRA’s strong support for Dr. Janet Woodcock to be nominated for Commissioner of the U.S. […] Read More

FDA Revoked Emergency Use Approval of Hydroxychloroquine for COVID-19

June 15, 2020 The U.S. Food and Drug Administration announced June 15 that it revoked approval called emergency use authorization (EUA) for hydroxychloroquine and chloroquine to be used to treat certain patients who had been hospitalized for COVID-19. The FDA made this decision based on its ongoing analysis of the scientific data from current studies […] Read More

Aurinia Completes NDA and Requests Priority Review of Voclosoporin by FDA for Lupus Nephritis

May 28, 2020 The Lupus Research Alliance is pleased to share that Aurinia Pharmaceuticals Inc submitted a New Drug Application (NDA) to the U.S. FDA for voclosporin as a potential treatment for lupus nephritis with request for a priority review. Lupus nephritis is one of the most common complications of systemic lupus erythematosus, a serious […] Read More

Lupus and COVID-19: What You Need to Know – LIVE WEBCAST May 21 at 6 PM ET

Since the arrival of the novel coronavirus, lupus and the most prescribed drug used to treat it – hydroxychloroquine – have been thrust into the public spotlight despite the mounting scientific evidence that drug does not appear to improve clinical outcomes in patients with COVID-19. What has been talked about less is what the impact […] Read More

Lupus Research Alliance Thanks FDA for Responsiveness Re Letter Citing Plaquenil Shortages

May 7, 2020 The Lupus Research Alliance held an informative call with the Food and Drug Administration (FDA) in response to the letter spearheaded by the Lupus Research Alliance (LRA) Scientific Advisory Board Chair, Dr. Gary Koretzky, and co-signed by more than a dozen international leaders in Immunology, Rheumatology and Bioethics representing academia, industry and […] Read More

Actions from Pharmaceutical Companies to Preserve Hydroxychloroquine (Plaquenil) Supply

March 30, 2020 The rheumatology community has been in discussions with the U.S. Food and Drug Administration and many pharmaceutical companies about the potential shortage of hydroxychloroquine (brand name Plaquenil) in the COVID-19 epidemic, and we are seeing much progress to increase its production and availability. The LRA especially thanks Sandoz, the generics division of […] Read More