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Maroc Maroc - ZACKS.COM - All Stories - 30/Aug 16:07

JNJ Seeks First FDA Nod for Autoimmune Disease Drug Nipocalimab

The Johnson & Johnson filing seeks the FDA's approval for nipocalimab to treat generalized myasthenia gravis in a broad population of antibody-positive patients.

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Travere Gains 11% on Securing Full FDA Nod for Kidney Disease Drug

zacks.com - 09/Sep 15:58

The approval expands the label of TVTX's Filspari in IgAN indication. However, the label also comes with a boxed warning for liver problems and...

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Travere Gains 11% on Securing Full FDA Nod for Kidney Disease Drug

zacks.com - 09/Sep 15:58

The approval expands the label of TVTX's Filspari in IgAN indication. However, the label also comes with a boxed warning for liver problems and...

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Tremfya (guselkumab) Receives U.S. FDA Approval for Adults with Moderately to Severely Active Ulcerative Colitis

drugs.com - 13/Sep 07:09

HORSHAM, Pa. (September 11, 2024) – Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved...

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Tremfya (guselkumab) Receives U.S. FDA Approval for Adults with Moderately to Severely Active Ulcerative Colitis

drugs.com - 13/Sep 07:09

HORSHAM, Pa. (September 11, 2024) – Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved...

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Regeneron, SNY Win FDA Approval for a Broader Dupixent Label

zacks.com - 17:19

REGN gets FDA nod for Dupixent for a broader population for the indication of chronic rhinosinusitis with nasal polyps.

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Amneal Stock Rises 29% in a Month on Upbeat Regulatory Updates

zacks.com - 03/Sep 14:54

AMRX stock gains 29.3% in a month due to the FDA's approval of Parkinson's Disease drug, Crexont.

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ITRM Posts Updates From FDA Advisory Meeting for UTI Drug, Stock Down

zacks.com - 11/Sep 16:04

Iterum provides updates from the FDA's Antimicrobial Drugs Advisory Committee meeting on its NDA for oral sulopenem to treat adult women with uUTI.

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More ASF vaccine makers seek FDA nod–DA

businessmirror.com.ph - 11/Sep 13:06

Providers of vaccines against African swine fever (ASF) from four countries are seeking the Food and Drug Administration’s (FDA) approval, according...

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More ASF vaccine makers seek FDA nod–DA

businessmirror.com.ph - 11/Sep 13:06

Providers of vaccines against African swine fever (ASF) from four countries are seeking the Food and Drug Administration’s (FDA) approval, according...

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First Patients Treated in Phase 2 Clinical Trial of STAT3 Inhibitor in Combination with Radiation for the Treatment of Glioblastoma

drugs.com - 09/Sep 20:09

HOUSTON, Sept. 9, 2024. Moleculin Biotech, Inc., ("Moleculin" or the "Company), a Phase 3 clinical-stage pharmaceutical company with a broad portfolio...