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Astellas Pharma Inc. and YASKAWA Electric Corporation signed a definitive agreement to establish a joint venture for the development of a cell therapy product manufacturing platform…
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AbbVie and Gubra A/S, a company specializing in preclinical contract research services and peptide-based drug discovery within metabolic and fibrotic diseases, announced a license…
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AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been recommended for approval in the European Union (EU) for the treatment of adults with resectable non-small…
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Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) has approved TNKase (tenecteplase), a thrombolytic or clot-dissolving agent, for the…
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Sobi announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Gamifant (emapalumab-Izsg) for use in adult and…
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Regeneron Pharmaceuticals, Inc. announced that the  U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for…
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Eli Lilly and Company announced at a press conference in Washington, D.C., plans to bolster its domestic medicine production across therapeutic areas by building four new pharmaceutical…
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Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Opdivo (nivolumab) plus Yervoy …
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Gilead Sciences, Inc. announced that the European Medicines Agency (EMA) has validated for parallel accelerated review the company’s Marketing Authorization Application (MAA) and…
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Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Alvotech announced the availability of SELARSDI (ustekinumab-aekn) injection in the U.S., a biosimilar…
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Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to its new drug application for zongertinib (BI 1810631) for the treatment of…
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The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults with bullous…
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Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir—the company’s twice-yearly…
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Galderma announced that the European Commission has approved Nemluvio for both moderate-to-severe atopic dermatitis and prurigo nodularis in the European Union (EU). Nemluvio is now…
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The FDA has granted Fast Track Designation to Lundbeck’s investigational drug, amlenetug, a potential new treatment option targeting Multiple System Atrophy (MSA). Lundbeck has recently…
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AbbVie and Xilio Therapeutics, Inc. a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, announced…
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Boehringer Ingelheim announced that the FIBRONEER-ILD trial met its primary endpoint, which was the absolute change from baseline in forced vital capacity (FVC) at week 52 versus…
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Novartis announced that it has entered into an agreement to acquire Anthos Therapeutics, Inc., a Boston-based, privately held, clinical-stage biopharmaceutical company with abelacimab,…
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AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved EMBLAVEO (aztreonam and avibactam), as the first and only fixed-dose, intravenous, monobactam/β-lactamase…
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DEBRA Research GmbH, a non-profit organization dedicated to advancing research, advocacy, and support for those affected by Epidermolysis Bullosa (EB) and LEO Pharma, a global leader in…
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