The Food and Drug Administration approved on Friday a label change for Pfizer's birth control shot Depo-Provera that warns patients of the risk of meningioma, a tumor in the lining of the brain.
FDA-approved updates for Breyanzi and Abecma reduce patient monitoring and eliminate REMS, enhancing access to CAR T-cell therapies. Labeling changes reflect increased regulatory confidence in the ...
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Bristol Myers, Gilead, J&J, Novartis win favorable FDA label updates for cell therapies
The U.S. Food and Drug Administration (FDA) has approved several label updates for CAR-T cell therapies marketed by Bristol Myers Squibb (NYSE:BMY), Gilead Sciences (NASDAQ:GILD), J&J (NYSE:JNJ), and ...
The FDA has approved an updated label for beremagene geperpavec-svdt (B-VEC), a topical gene therapy for dystrophic epidermolysis bullosa (DEB), which expands the indication from ages 6 months and ...
PITTSBURGH, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that the United States Food and Drug Administration (FDA) approved a label update ...
Incyte INCY announced that the FDA has approved the label expansion of Opzelura (ruxolitinib) cream 1.5%. Opzelura, a topical Janus kinase (JAK) inhibitor, is now approved for the short-term and ...
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