News

Pfizer has released compelling new data from its Phase 3 HER2CLIMB-05 clinical trial, showing that the company’s tyrosine kinase inhibitor, TUKYSA® (tucatinib), significantly improved…
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Zydus Lifesciences has announced a major strategic partnership with Germany-based Formycon AG to develop and commercialize FYB206, a biosimilar version of the blockbuster immunotherapy…
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Ajax Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to AJ1-11095, the company’s next-generation JAK inhibitor being…
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Eli Lilly and Company has announced plans to invest over $6 billion in a new manufacturing facility in Huntsville, Alabama, aimed at producing next-generation synthetic medicine active…
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Amneal Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved its epinephrine injection USP, 1 mg/mL, in both single-dose (1 mL) and multi-dose (30 mL)…
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Pfizer has entered into a global collaboration and licensing agreement with YaoPharma, a subsidiary of Shanghai Fosun Pharmaceutical Group, to advance the development of YP05002, an…
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Roche announced that the European Commission has granted approval for Gazyva®/Gazyvaro® (obinutuzumab) combined with mycophenolate mofetil (MMF) to treat adults with active Class III or…
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Inductive Bio, an AI-driven drug discovery company known for developing virtual chemistry laboratories, has been awarded up to $21 million to lead a groundbreaking project aimed at…
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Viatris Inc. has entered into definitive agreements with Biocon Limited for the sale of its full equity stake in Biocon Biologics Limited, marking a major strategic move as the company…
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Ionis Pharmaceuticals has received a significant boost in its neurology pipeline with the U.S. Food and Drug Administration granting Breakthrough Therapy designation to zilganersen, the…
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Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has granted expanded approval for Jaypirca (pirtobrutinib) for adults with relapsed or refractory…
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Taiwan-based Formosa Pharmaceuticals (6838.TW) has entered into an exclusive licensing agreement with Singapore-headquartered Rxilient Medical Pte. Ltd., granting the company…
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Global biopharmaceutical contract development and manufacturing organization (CDMO) AGC Biologics has announced a major expansion of its Cell Line Development Center of Excellence…
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The U.S. Food and Drug Administration (FDA) has appointed Tracy Beth Høeg, M.D., Ph.D., as the acting director of the Center for Drug Evaluation and Research (CDER), marking a…
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The U.S. Food and Drug Administration (FDA) has issued new draft guidance identifying specific drug product types for which six-month non-human primate (NHP) toxicity studies can be…
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Citizen Health has announced a major strategic partnership with UCB, a global biopharmaceutical leader in neurological and autoimmune research, to accelerate drug discovery and…
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IQVIA has announced a major strategic collaboration with Amazon Web Services (AWS), naming the cloud company as its Preferred Agentic Cloud Provider—a move set to accelerate the digital…
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Ionis Pharmaceuticals has announced a major regulatory milestone for its investigational therapy olezarsen, as the U.S. Food and Drug Administration (FDA) has granted it Breakthrough…
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Lupin Limited has secured a key regulatory milestone with the U.S. Food and Drug Administration granting approval to Armlupeg™ (pegfilgrastim-unne), the company’s first biosimilar to…
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Regeneron Pharmaceuticals and Tessera Therapeutics have entered into a major global collaboration to advance TSRA-196, an investigational in vivo Gene Writing therapy designed to…
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