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FDA Approves Updated Label for Lilly’s Amyvid to Aid Alzheimer’s Diagnosis

Jun 26, 2025
Eli Lilly and Company announced that the U.S. FDA has approved a label update for Amyvid (florbetapir F 18 injection) for intravenous use. Amyvid is used for brain imaging to estimate…
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Vor Bio, RemeGen Sign Exclusive Global License Deal for Late-Stage Autoimmune Therapy

Jun 26, 2025
Vor Bio, Inc. has entered into an exclusive global licensing agreement with Chinese biopharmaceutical company RemeGen Co., Ltd., gaining rights to develop and commercialize the…
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Medera’s Novoheart Teams Up to Develop Mini-Heart Models for Hypoplastic Left Heart Syndrome…

Jun 25, 2025
Medera Inc., a clinical-stage biopharmaceutical company focused on cardiovascular disease therapies, and its pre-clinical subsidiary Novoheart, specializing in human cardiac tissue…
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Novo Nordisk’s Ozempic Recommended by EU for Peripheral Arterial Disease in Type 2 Diabetes

Jun 24, 2025
Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion to update the label of Ozempic…
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Datroway Approved in U.S. for Advanced EGFR-Mutated Lung Cancer

Jun 24, 2025
The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Datroway (datopotamab deruxtecan or Dato-DXd) for the treatment of adult patients with locally advanced…
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argenx Wins EU Approval for VYVGART SC to Treat CIDP

Jun 24, 2025
argenx SE, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced that the European Commission (EC) approved VYVGART…
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Harbour BioMed and Otsuka Partner Globally to Develop BCMAxCD3 Bispecific T-Cell Engagers

Jun 24, 2025
Harbour BioMed, a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, announced a global strategic…
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Archeus Technologies Gets FDA Clearance for ART-101 Prostate Cancer Trial

Jun 23, 2025
Archeus Technologies announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ART-101, a novel receptor-based targeting…
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Health Canada Approves Novartis’ KISQALI for High-Risk Early Breast Cancer

Jun 23, 2025
Health Canada has approved Novartis' KISQALI (ribociclib tablets) in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor-positive (HR+),…
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Advarra Launches AI Council to Boost Innovation in Clinical Trials

Jun 20, 2025
Advarra announced the launch of the Council for Responsible Use of AI in Clinical Trials. The Council, which includes leaders from across the life sciences industry, will focus on…
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