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Maroc Maroc - DRUGS.COM - New Drug Approvals - 24/Jul 01:07

U.S. Food and Drug Administration Approves BioMarin's Brineura (cerliponase alfa) for Children Under 3 Years with CLN2 Disease

SAN RAFAEL, Calif., July 24, 2024 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application (sBLA) for Brineura...

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KalVista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary Angioedema

drugs.com - 03/Sep 20:09

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--Sep. 3, 2024-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that the U.S....

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FDA Approves Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy

drugs.com - 12/Sep 08:09

South San Francisco, CA -- September 12, 2024 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S....

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FDA Approves Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy

drugs.com - 12/Sep 08:09

South San Francisco, CA -- September 12, 2024 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S....

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FDA Approves Tremfya for Ulcerative Colitis

drugs.com - 22:24

MONDAY, Sept. 16, 2024 -- The U.S. Food and Drug Administration has approved Tremfya (guselkumab) for the treatment of adults with moderately to...

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FDA Approves Tremfya for Ulcerative Colitis

drugs.com - 22:24

MONDAY, Sept. 16, 2024 -- The U.S. Food and Drug Administration has approved Tremfya (guselkumab) for the treatment of adults with moderately to...

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Unicycive Therapeutics Announces Submission of the New Drug Application (NDA) to the U.S. FDA for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis

drugs.com - 03/Sep 01:09

LOS ALTOS, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing...

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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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FDA extends review period for Medexus’ treosulfan to 2025

themarketherald.ca - 17:41

Medexus Pharmaceuticals (TSX:MDP) reveals the U.S. FDA has extended the review period for the company's new drug application for treosulfan.

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FDA extends review period for Medexus’ treosulfan to 2025

themarketherald.ca - 17:41

Medexus Pharmaceuticals (TSX:MDP) reveals the U.S. FDA has extended the review period for the company's new drug application for treosulfan.

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