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The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for the investigational use of Sarclisa (isatuximab)…
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Celltrion today announced that the European Commission (EC) has approved Omlyclo (CT-P39), an omalizumab biosimilar referencing Xolair. Omlyclo is approved for the treatment of allergic…
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Biogen Inc. and Human Immunology Biosciences (HI-Bio), a privately-held clinical-stage biotechnology company focused on targeted therapies for patients with severe immune-mediated…
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Sandoz, the global leader in generic and biosimilar medicines, announced that the European Commission (EC) has granted marketing authorization for Wyost(denosumab) and Jubbonti…
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Nona Biosciences, a global biotechnology company providing a total solution from "Idea to IND" (I to ITM), ranging from target validation and antibody discovery through preclinical…
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Sanofi, Formation Bio and OpenAI are collaborating to build AI-powered software to accelerate drug development and bring new medicines to patients more efficiently. The three teams will…
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AltruBio Inc., a clinical stage biotechnology company dedicated to the development of novel therapeutics for the treatment of immunological diseases with high unmet medical needs,…
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Genmab A/S announced that it has completed its acquisition of ProfoundBio, Inc., a clinical-stage biotechnology company developing next-generation antibody-drug conjugates (ADC)s and…
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AstraZeneca intends to build a $1.5 billion manufacturing facility in Singapore for antibody drug conjugates (ADCs), enhancing global supply of its ADC portfolio. ADCs are…
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Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide (“Alvotech”), and Dr. Reddy’s Laboratories SA,…
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