News

OMass Therapeutics, a biotech company specializing in medicines targeting complex protein ecosystems, has entered into an exclusive collaboration and license agreement with Genentech, a…
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Shanghai Henlius Biotech, Inc. and Organon have announced that the U.S. Food and Drug Administration (FDA) has approved BILDYOS (denosumab-nxxp) and BILPREVDA (denosumab-nxxp),…
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Boehringer Ingelheim announced that its drug HERNEXEOS (zongertinib tablets) has received approval from China’s National Medical Products Administration (NMPA) as a monotherapy…
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Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for LEQEMBI IQLIK (lecanemab-irmb)…
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Santhera Pharmaceuticals has entered into an exclusive agreement with Ikris Pharma Network to distribute AGAMREE (vamorolone) in India. The drug is approved for treating Duchenne…
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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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