JNJ's Nipocalimab Gets FDA's Fast Track Tag for Sjogren's Disease [Yahoo! Finance]
Gilead Sciences, Inc. (GILD)
Last gilead sciences, inc. earnings: 4/30 04:01 pm
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Source: Yahoo! Finance
adult patients with moderate-to-severe Sjögren's disease (“SjD”), a chronic autoimmune disease. Currently, there are no advanced therapies approved by the FDA for the given indication. The Fast Track designation from the FDA facilitates rapid development and expedites the review of drug candidates that are being developed to treat serious conditions and for which clinical data demonstrate the potential to address unmet medical needs. The goal is to make these treatments rapidly available to patients in need. Besides SjD, the FDA has granted FTD to nipocalimab in three other indications, hemolytic disease of the fetus and newborn (“HDFN”) and warm autoimmune hemolytic anemia (wAIHA), generalized myasthenia gravis (gMG) and fetal neonatal
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GILD
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