News

The U.S. Food and Drug Administration (FDA) has approved Wayrilz (rilzabrutinib), an oral Bruton’s tyrosine kinase (BTK) inhibitor, for adults with persistent or chronic immune…
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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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China’s National Medical Products Administration (NMPA) has approved DATROWAY (datopotamab deruxtecan) for the treatment of adults with unresectable or metastatic hormone receptor (HR)…
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Genentech, a member of the Roche Group, officially broke ground on its newest U.S. manufacturing site in Holly Springs, North Carolina, marking a major milestone as the biotech giant…
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AbbVie and Gilgamesh Pharmaceuticals have entered into a definitive agreement under which AbbVie will acquire Gilgamesh’s lead investigational candidate, bretisilocin, a next-generation…
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Valneva SE announced that the U.S. Food and Drug Administration (FDA) has suspended the license for its chikungunya vaccine IXCHIQ, following reports of four new serious adverse events…
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Eli Lilly and Company announced that its investigational oral GLP-1 receptor agonist, orforglipron, delivered significant weight loss and blood sugar control in a Phase 3 clinical trial…
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Kite, a Gilead Company, announced it will acquire Interius BioTherapeutics, a privately held biotech firm pioneering in vivo CAR therapies, in a $350 million deal aimed at advancing…
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Johnson & Johnson has announced a major expansion of its U.S. manufacturing capabilities with a $2 billion, 10-year investment in a new 160,000+ square foot facility at FUJIFILM’s…
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Andelyn Biosciences, Inc., a leading contract development and manufacturing organization (CDMO) specializing in cell and gene therapies, has announced a new partnership with Amplo…
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Ionis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved DAWNZERA (donidalorsen) for prophylaxis to prevent attacks of hereditary angioedema…
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