Latest News for: fda approval

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Johnson & Johnson seeks FDA approval of IMAAVY® (nipocalimab-aahu) as the first-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA)

PR Newswire 24 Feb 2026
Currently no FDA-approved therapies are available for wAIHA, a rare, heterogeneous, life-threatening disease in which pathogenic immunoglobulin (IgG) autoantibodies attach to and destroy red blood cells, leading to debilitating anemia.
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Johnson & Johnson seeks FDA approval of IMAAVY® (nipocalimab-aahu) as the first-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA) (Johnson & Johnson)

Public Technologies 24 Feb 2026
Johnson & Johnson seeks FDA approval of IMAAVY® (nipocalimab-aahu) as the rst-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA) ... Currently no FDA-approved therapies are ...
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Allurion Receives U.S. FDA Approval

Rutland Herald 23 Feb 2026
NATICK, Mass.--(BUSINESS WIRE)--Feb 23, 2026-- ....
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LIVE NOW: HHS Announces FDA Approval Pathway for Individualized Therapies

The Epoch Times 23 Feb 2026
The Department of Health and Human Services (HHS) announces the FDA’s approval pathway for individualized drug and biologics therapies at 11.30 a.m. ET on Feb. 23 ....
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FDA Approves VUEWAY® (gadopiclenol) Solution for Injection, Intravenous Use, for Use in Neonates and Infants

PR Newswire 23 Feb 2026
Food and Drug Administration (FDA) has approved the extension of the current VUEWAY® (gadopiclenol) solution for injection, intravenous use, for use in neonates and infants ... https.//www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2022.
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Roche obtains FDA approval to treat chronic lymphocytic leukaemia

Swissinfo 20 Feb 2026
Genentech, a US subsidiary of Roche, has obtained approval from the United States Food and Drug Administration (FDA) for a treatment for chronic lymphocytic leukaemia (CLL) ... Translated ... .
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