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Maroc Maroc - DRUGS.COM - New Drug Approvals - 07/Mar 22:03

FDA Approves Omlyclo (omalizumab-igec), an Interchangeable Biosimilar to Xolair

March 07, 2025 -- Today, the U.S. Food and Drug Administration approved as the first interchangeable biosimilar to Xolair (omalizumab). Omlyclo, like Xolair, is approved to treat the following conditions: Moderate to severe persistent asthma in...

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FDA Approves Stoboclo (denosumab-bmwo), a Biosimilar to Prolia

drugs.com - 03/Mar 00:03

JERSEY CITY, N.J., March 3, 2025 /PRNewswire/ -- Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved Stoboclo...

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FDA Approves Osenvelt (denosumab-bmwo), a Biosimilar to Xgeva

drugs.com - 03/Mar 00:03

JERSEY CITY, N.J., March 3, 2025 /PRNewswire/ -- Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved Osenvelt...

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FDA Approves TNKase (tenecteplase) for the Treatment of Acute Ischemic Stroke in Adults

drugs.com - 03/Mar 22:03

South San Francisco, CA -- March 3, 2025 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food...

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FDA Approves Odactra for the Treatment of House Dust Mite Allergy in Young Children

drugs.com - 28/Feb 23:02

February 27, 2025 -- ALK (ALKB:DC / OMX: ALK B) today announced that the US Food and Drug Administration (FDA) has approved ALK’s Odactra tablet...

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FDA Approves TNKase for Acute Ischemic Stroke

drugs.com - 06/Mar 21:06

THURSDAY, March 6, 2025 -- The U.S. Food and Drug Administration has approved TNKase (tenecteplase), a thrombolytic or clot-dissolving agent, for the...

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Pyxis Oncology Granted FDA Fast Track Designation for PYX-201 Monotherapy in Patients with Recurrent or Metastatic Head and Neck Cancer

drugs.com - 26/Feb 04:02

BOSTON, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for...

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FDA Approves Encelto (revakinagene taroretcel-lwey) for the Treatment of Macular Telangiectasia Type 2 (MacTel)

drugs.com - 06/Mar 22:03

CUMBERLAND, R.I.--(BUSINESS WIRE)--Neurotech Pharmaceuticals, Inc., a private biotech company focused on developing transformative therapies for...

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Omalizumab Treats Multi-Food Allergy Better Than Oral Immunotherapy

drugs.com - 03/Mar 20:03

Monday, March 3, 2025 -- A clinical trial has found that the medication omalizumab, marketed as Xolair, treated multi-food allergy more effectively...

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FDA Approves Miudella (copper intrauterine system) for the Prevention of Pregnancy

drugs.com - 24/Feb 22:02

ROSWELL, GA, February 24, 2025 – Sebela Women’s Health Inc., a part of Sebela Pharmaceuticals, today announced that the U.S. Food and Drug...

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Indivior Announces FDA Approval of Label Changes for Sublocade (buprenorphine extended-release) Injection

drugs.com - 24/Feb 23:02

Richmond, VA, February 24, 2025 – Indivior PLC (Nasdaq/LSE: INDV), a global leader in addiction treatment, today announced that the U.S. Food...

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