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Maroc Maroc - DRUGS.COM - Pharma Industry News - 03/12/2025 16:12

FDA Approves Updated Label for Unloxcyt

WEDNESDAY, Dec. 3, 2025 -- The U.S. Food and Drug Administration has approved an updated label for Unloxcyt (cosibelimab-ipdl) for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not...

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FDA Approves Myqorzo for Symptomatic Obstructive Hypertrophic Cardiomyopathy

drugs.com - 05/Jan 22:53

MONDAY, Jan. 5, 2026 -- The U.S. Food and Drug Administration has approved Myqorzo (aficamten) for the treatment of adults with symptomatic...

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Breakthrough In Acute Pain Management: FDA Approves First-In-Class Non-Opioid

dailywire.com - 08/Jan 12:29

On Thursday, the U.S. Food and Drug Administration (FDA) approved Journavx (suzetrigine) 50 mg oral tablets, a first-in-class non-opioid analgesic for...

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Breakthrough In Acute Pain Management: FDA Approves First-In-Class Non-Opioid

dailywire.com - 08/Jan 12:29

On Thursday, the U.S. Food and Drug Administration (FDA) approved Journavx (suzetrigine) 50 mg oral tablets, a first-in-class non-opioid analgesic for...

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FDA Approves Zycubo (copper histidinate) for Children With Menkes Disease

drugs.com - 12/Jan 22:01

January 12, 2026 -- The U.S. Food and Drug Administration today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes...

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FDA Approves Zycubo (copper histidinate) for Children With Menkes Disease

drugs.com - 12/Jan 22:01

January 12, 2026 -- The U.S. Food and Drug Administration today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes...

FDA Approves First Oral Drug for Thalassemia Anemia

medindia.net - 12/Jan 14:57

FDA approves Mitapivat, the first oral treatment for thalassemia anemia, helping reduce transfusion needs and raise hemoglobin levels in adults.

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Camurus Announces FDA Acceptance of NDA Resubmission for Oclaiz for the Treatment of Acromegaly

drugs.com - 09/Jan 20:01

LUND, Sweden, Jan. 9, 2026 /PRNewswire/ -- Camurus (NASDAQ STO: CAMX) today announced that the U.S. Food and Drug Administration (FDA) has accepted...

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Camurus Announces FDA Acceptance of NDA Resubmission for Oclaiz for the Treatment of Acromegaly

drugs.com - 09/Jan 20:01

LUND, Sweden, Jan. 9, 2026 /PRNewswire/ -- Camurus (NASDAQ STO: CAMX) today announced that the U.S. Food and Drug Administration (FDA) has accepted...

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FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation

mangaloremirror.com - 12/Jan 02:54

White Oak, Md., Jan. 12, 2026 (GLOBE NEWSWIRE) — The U.S. Food and Drug Administration today announced it is sharing information about the...

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FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation

mangaloremirror.com - 12/Jan 02:54

White Oak, Md., Jan. 12, 2026 (GLOBE NEWSWIRE) — The U.S. Food and Drug Administration today announced it is sharing information about the...