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Sandoz Launches Rivaroxaban in Germany, Broadening Access to Antithrombotic Care

Aug 29, 2025
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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IQVIA and Flagship Pioneering Partner to Accelerate Breakthroughs in Life Sciences

Aug 29, 2025
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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Zemcelpro Wins EC Approval as First Cell Therapy for Blood Cancer Patients Without Suitable Donors

Aug 29, 2025
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 Earns FDA RMAT Status for Stem Cell Therapy in Relapsing-Remitting MS

Aug 29, 2025
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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RINVOQ Receives Health Canada Approval for Giant Cell Arteritis in Adults

Aug 29, 2025
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 Issues FDA Review Update on ONS-5010 for Wet AMD

Aug 29, 2025
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 and BioNTech’s COMIRNATY Gets FDA Approval for Seniors and High-Risk Individuals Ages 5-64

Aug 28, 2025
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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EU Approves Twice-Yearly Yeytuo (Lenacapavir) for HIV Prevention

Aug 27, 2025
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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DATROWAY Approved in China for Previously Treated HR+/HER2- Metastatic Breast Cancer

Aug 27, 2025
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 and Roche Break Ground on New Manufacturing Facility in North Carolina

Aug 27, 2025
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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