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Maroc Maroc - DRUGS.COM - Pharma Industry News - 26/Sep 16:09

FDA Approves Bimzelx for Three New Indications

THURSDAY, Sept. 26, 2024 -- The U.S. Food and Drug Administration has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), adults with active nonradiographic axial spondyloarthritis (nr-axSpA) with o...

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FDA Approves Cobenfy for Adults With Schizophrenia

drugs.com - 14/Nov 23:11

THURSDAY, Nov. 14, 2024 -- The U.S. Food and Drug Administration has approved Cobenfy (xanomeline and trospium chloride), a first-in-class muscarinic...

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FDA Approves Emrosi for Rosacea in Adults

drugs.com - 12/Nov 21:33

TUESDAY, Nov. 12, 2024 -- The U.S. Food and Drug Administration has approved Emrosi (minocycline hydrochloride) for the treatment of inflammatory...

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FDA Approves Emrosi for Rosacea in Adults

drugs.com - 12/Nov 21:33

TUESDAY, Nov. 12, 2024 -- The U.S. Food and Drug Administration has approved Emrosi (minocycline hydrochloride) for the treatment of inflammatory...

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Nipocalimab is the First and Only Investigational Therapy Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Adults Living with Moderate-to-Severe Sjögren’s Disease

drugs.com - 11/Nov 02:11

Spring House, PA (November 11, 2024) – Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has...

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FDA Approves Aucatzyl (obecabtagene autoleucel) for Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

drugs.com - 08/Nov 21:11

LONDON, Nov. 08, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early-commercial stage biopharmaceutical company developing...

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FDA Approves Kebilidi (eladocagene exuparvovec-tneq) Gene Therapy for the Treatment of AADC Deficiency

drugs.com - 13/Nov 02:11

WARREN, N.J., Nov. 13, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the U.S. Food and Drug Administration (FDA)...

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Ionis Announces FDA Acceptance of New Drug Application for Donidalorsen for Prophylactic Treatment of HAE

drugs.com - 04/Nov 23:11

CARLSBAD, Calif., Nov. 4, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration...

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Abeona Therapeutics Announces FDA Acceptance of BLA Resubmission of Pz-cel for the Treatment of Recessive Dystrophic Epidermolysis Bullosa

drugs.com - 12/Nov 20:11

CLEVELAND, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the U.S. Food and Drug Administration (FDA)...

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FDA Approves Emrosi (minocycline hydrochloride) for the Treatment of Rosacea

drugs.com - 04/Nov 00:11

SCOTTSDALE, Ariz., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage...

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FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive Review

drugs.com - 07/Nov 00:11

November 07, 2024 -- Today, the U.S. Food and Drug Administration announced it is proposing to remove oral phenylephrine as an active ingredient that...

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