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FDA Approves LEQEMBI IQLIK Subcutaneous Injection for Early Alzheimer’s Maintenance Therapy

Sep 1, 2025
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 Partners with Ikris Pharma Network to Distribute AGAMREE in India

Sep 1, 2025
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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Sanofi’s Wayrilz Approved in US as First BTK Inhibitor for Immune Thrombocytopenia

Sep 1, 2025
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’ Leqvio Achieves Early LDL-C Goals with Less Muscle Pain

Sep 1, 2025
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 Partner Telix Pharmaceuticals Provides Regulatory Update on Imaging Agent…

Aug 29, 2025
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 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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Press Releases

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