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Novartis has announced encouraging results from its Phase IV V-DIFFERENCE study, which evaluated Leqvio (inclisiran) in patients with high cholesterol who had not met…
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Heidelberg Pharma AG announced that its licensing partner, Telix Pharmaceuticals, has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA)…
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Sandoz, a global leader in generic and biosimilar medicines, has launched generic rivaroxaban in Germany in new 10 mg, 15 mg, and 20 mg strengths, providing patients with a high-quality…
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Global clinical research and healthcare data leader IQVIA has announced a strategic collaboration with Flagship Pioneering, the venture firm behind transformative bioplatform companies,…
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ExCellThera Inc. and its subsidiary Cordex Biologics announced that Zemcelpro (UM171 Cell Therapy) has received conditional marketing authorization from the European Commission (EC) for…
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Hope Biosciences, a U.S.-based stem cell banking and therapeutic manufacturer, has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug…
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AbbVie announced that Health Canada has granted a Notice of Compliance (NOC) for RINVOQ (upadacitinib) for the treatment of adults with giant cell arteritis (GCA). The approval includes…
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Outlook Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding its biologics license application (BLA) for…
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Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) has approved their supplemental Biologics License Application (sBLA) for the LP.8.1-adapted…
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The European Commission (EC) has granted marketing authorization to Gilead Sciences for Yeytuo (lenacapavir), making it the first and only twice-yearly injectable HIV pre-exposure…
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