News

BeiGene, Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BGB-16673, an orally available investigational Bruton’s tyrosine kinase…
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ENHERTU (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of unresectable or metastatic hormone receptor positive…
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PANTHERx Rare, a leader in rare disease product patient access and support services in the United States, is pleased to announce it is partnering with Gilead Sciences, Inc. for the…
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Eli Lilly and Company announced the opening of the Lilly Seaport Innovation Center (LSC), a research and development facility in the Boston Seaport dedicated to advancing Lilly's…
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Incyte and Syndax Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Niktimvo (axatilimab-csfr), an anti-CSF-1R antibody, for the treatment of…
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Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi (seladelpar) for the treatment of primary biliary…
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AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has received conditional approval in China as a monotherapy for the treatment of adult patients with locally advanced…
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Replimune Group, Inc., a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, announced that the first patient has been…
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Pfizer Inc. announced positive top-line safety and immunogenicity results from substudy B of the ongoing pivotal Phase 3 clinical trial ( NCT05842967 ) MONeT (RSV I Mmunizati ONStudy…
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Ascendis Pharma A/S announced that the U.S. Food & Drug Administration (FDA) has approved YORVIPATH (palopegteriparatide; developed as TransCon PTH) for the treatment of…
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GSK Singapore announced that the Singapore Health Sciences Authority (HSA) has approved a new indication for Jemperli (dostarlimab), which may now be used in combination with…
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Daiichi Sankyo and Merck, known as MSD outside of the United States and Canada, have expanded their existing global co-development and co-commercialization agreement for three…
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Servier announced that the U.S. Food and Drug Administration (FDA) has approved VORANIGO, an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, indicated…
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Sangamo Therapeutics, Inc., a genomic medicine company, announced it has entered into a license agreement with Genentech, a member of the Roche Group, to develop intravenously…
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SK pharmteco, a global contract development, manufacturing, and analytical testing organization serving both the small molecule and cell & gene therapy industry, and Rznomics Inc.,…
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Roche announced that the European Commission (EC) has approved Vabysmo (faricimab) for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO,…
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Roche announced the completion of the acquisition of LumiraDx’s Point of Care technology, following the receipt of all required antitrust and regulatory clearances. Roche will now…
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Today marks a significant step for Boehringer Ingelheim’s immuno-oncology pipeline as the company is adding an innovative preclinical program with the acquisition of Nerio…
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Novartis announced that Scemblix (asciminib) has been granted Priority Review status by the US Food and Drug Administration (FDA) for treatment of newly diagnosed adult patients with…
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Sandoz, the global leader in generic and biosimilar medicines, announces the launch of Pyzchiva®* (ustekinumab) across Europe, starting today. Pyzchiva®, developed and registered by…
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