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FDA Approves Nucala (mepolizumab) for Six to 11-Year-Old Children with Severe Eosinophilic Asthma drugs
September 16, 2019
GlaxoSmithKline today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for use in children as young as six years old who are living with severe eosinophilic asthma.
FDA Approves Ibsrela (tenapanor) for the Treatment of Irritable Bowel Syndrome with Constipation drugs
September 16, 2019
Ardelyx, Inc. announced that the U.S. Food and Drug Administration has approved Ibsrela (tenapanor), a 50 mg, twice daily oral pill for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
Zantac May Contain Small Amounts of Known Carcinogen drugs
September 16, 2019
A substance that could cause cancer has been found in some ranitidine heartburn and ulcer medicines, including the brand-name drug Zantac...
FDA to Assess First Drug Meant to Prevent Peanut Allergy drugs
September 16, 2019
A panel of experts at the U.S. Food and Drug Administration is set to weigh the pros and cons of what could be the first drug ever approved to prevent peanut allergy.
FDA Approves Gvoke (glucagon), the First Ready-to-use Stable Liquid Glucagon for Severe Hypoglycemia drugs
September 12, 2019
Xeris Pharmaceuticals, Inc. a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations...
FDA Extends CRADA with CluePoints contractpharma
September 12, 2019
Aims to further explore a data-driven approach to quality oversight in clinical trials.
FDA Grants Fast Track to Amplyx for IV and Oral Formulations of Fosmanogepix americanpharmaceuticalreview
September 10, 2019
Amplyx Pharmaceuticals announced the U.S. Food & Drug Administration (FDA) has granted Fast Track designations for both the intravenous (IV) and oral formulations of the company's lead antifungal candidate...
First treatment for patients with rare lung disease approved europeanpharmaceuticalreview
September 10, 2019
The FDA has approved the first treatment for interstitial lung disease associated with systemic sclerosis or scleroderma.
FDA Approves Boehringer’s Ofev contractpharma
September 10, 2019
Becomes the first and only therapy to slow the rate of decline in pulmonary function in systemic sclerosis-associated ILD.
Wontech's Holmium laser receives FDA approval biospectrumasia
September 09, 2019
Holinwon Prima, approved by the FDA, is the first Holmium laser medical device developed in Korea.

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