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Tag: Food and Drug Administration

Lupus Accelerating Breakthroughs Consortium Announces Expanded Partnership with U.S. FDA at First Anniversary Meeting

BETHESDA, MD – [April 16] The Lupus Research Alliance (LRA), founder and administrator of the Lupus Accelerating Breakthroughs Consortium (Lupus ABC), announced today at the Consortium’s first anniversary meeting an expanded partnership with the U.S. Food and Drug Administration (FDA) with the inclusion of the Center for Biologics Evaluation and Research (CBER). The addition of […] 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

Important Message from CEO Kenneth Farber: U.S. FDA Approves New Lupus Treatment

August 2, 2021 Dear Friend of the Lupus Research Alliance, As we reported this morning, the lupus community has much to celebrate with the U.S. Food and Drug Administration (FDA) approval of anifrolumab-fnia (brand name, Saphnelo™). As a first-in-class and only new treatment for systemic lupus erythematosus in a decade, this approval marks a major […] Read More

New Data Points Away from Hydroxychloroquine as COVID-19 Treatment

Updated April 23, 2020 The most commonly prescribed treatment for lupus, hydroxychloroquine (best known as Plaquenil) is not effective for treating COVID-19 according to a new study of 368 hospitalized patients in United States Veteran Administration medical centers. Led by Mr. Joseph Magagnoli, Dr. Siddharth Narendran and Dr. Felipe Pereira at University of South Carolina, […] Read More

Letter from LRA to Top U.S. Health Officials

  April 12, 2020 Today, the Lupus Research Alliance (LRA) Scientific Advisory Board Chair Dr. Gary Koretzky emailed top federal health officials a strong letter calling attention to concerns about availability of hydroxychloroquine for patients with systemic lupus erythematosus. The letter was addressed to:  Alex M. Azar II, JD, Secretary, Health and Human Services; Stephen […] Read More

Aurinia Moves Voclosporin Closer to FDA Approval for Lupus Nephritis

March 16, 2020 The Lupus Research Alliance is pleased to share an announcement from Aurinia Pharmaceuticals that moves its potential treatment for lupus nephritis, voclosporin, one step closer to approval by the U.S. Food and Drug Administration (FDA).  The Company announced in a press release March 16 that it has started a Rolling Submission of […] Read More

The U.S. Department of Health and Human Services Accepts Donations of Hydroxychloroquine as Possible Treatments for COVID-19 Patients

March 31, 2020 A statement issued March 29 by the U.S. Department of Health and Human Services (HHS) announced that millions of donated doses of hydroxychloroquine sulfate and chloroquine phosphate had been accepted into the Strategic National Stockpile. In addition, the statement announced that the Food and Drug Administration has granted Emergency Use Authorization (EUA) […] Read More

It’s Not Too Late to Advocate for Lupus Research!

March, 2020 Congress will be working on the Fiscal Year 2021 budget for weeks to come, so you can still make your voice heard for lupus research.  If you haven’t already, please go online TODAY and use the automated tools of our Legislative Action Center to tell legislators what lupus research means to their constituents […] Read More
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