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Maroc Maroc - DRUGS.COM - Pharma Industry News - 30/Jun 00:06

Monthly News Roundup - June 2024

FDA Grants Expanded Approval to Skyrizi for Ulcerative Colitis On June 18th, the U.S. Food and Drug Administration (FDA) approved AbbVie’s Skyrizi (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis (UC)...

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Epkinly (epcoritamab-bysp) Approved by U.S. FDA for Patients with Relapsed or Refractory (R/R) Follicular Lymphoma (FL)

drugs.com - 27/Jun 04:06

COPENHAGEN, Denmark; June 27, 2024 – Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has approved...

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Harmony Biosciences Receives U.S. Food And Drug Administration Approval for Wakix (pitolisant) In Pediatric Patients With Narcolepsy

drugs.com - 24/Jun 23:06

PLYMOUTH MEETING, Pa., June 24, 2024 /PRNewswire/ -- Harmony Biosciences (Nasdaq: HRMY) today announced that the U.S. Food and Drug Administration...

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FDA Expands Approval for Duchenne Muscular Dystrophy Gene Therapy

drugs.com - 24/Jun 21:21

MONDAY, June 24, 2024 -- The U.S. Food and Drug Administration has expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene...

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AbbVie Provides U.S. Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa)

drugs.com - 25/Jun 21:06

NORTH CHICAGO, Ill., June 25, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it received a Complete Response Letter (CRL) from the U.S. Food...

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FDA Approves Tepylute (thiotepa) Ready-to-Dilute Injectable Formulation to Treat Breast Cancer and Ovarian Cancer

drugs.com - 28/Jun 22:06

CAMBRIDGE, Mass.--(BUSINESS WIRE) June 28, 2024 --Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced...

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FDA Expands Pediatric Indication for Rinvoq

drugs.com - 21/Jun 23:00

FRIDAY, June 21, 2024 -- The U.S. Food and Drug Administration has expanded indications for Rinvoq (upadacitinib) to now include pediatric patients...

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FDA Approves Kisunla (donanemab-azbt) for the Treatment of Early Symptomatic Alzheimer's Disease

drugs.com - 02/Jul 19:07

INDIANAPOLIS, July 2, 2024 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) approved Kisunla™ (donanemab-azbt, 350 mg/20 mL...

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FDA Approves KEYTRUDA + Chemo for Primary Advanced, Recurrent Endometrial Carcinoma

drugs.com - 21/Jun 22:55

FRIDAY, June 21, 2024 -- The U.S. Food and Drug Administration has approved Keytruda (pembrolizumab) plus chemotherapy as treatment for adult...

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FDA Approves Capvaxive Pneumococcal 21-Valent Conjugate Vaccine

drugs.com - 21/Jun 22:51

FRIDAY, June 21, 2024 -- The U.S. Food and Drug Administration has approved the Capvaxive pneumococcal 21-valent conjugate vaccine for the prevention...