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GSK plc announced that the European Medicines Agency (EMA) has accepted the company’s regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus…
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Takeda announced that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID as an intravenous immunoglobulin (IVIG) therapy to improve neuromuscular disability and…
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AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US for…
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Sanofi and Inhibrx, Inc. (“Inhibrx”), a publicly traded clinical-stage biopharmaceutical company focused on developing a broad pipeline of novel biologic therapeutic candidates, have…
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Sandoz, the global leader in generic and biosimilar medicines, has signed an agreement to acquire the US biosimilar ranibizumab CIMERLI (ranibizumab-eqrn) from Coherus BioSciences, Inc.…
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Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for BALVERSA (erdafitinib) for the treatment…
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Roche announced that the European Commission has granted marketing authorisation for Tecentriq SC (atezolizumab), the European Union (EU)’s first PD-(L)1 cancer immunotherapy for…
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Takeda announced that the U.S. Food and Drug Administration (FDA) has approved HYQVIA  for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance…
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GSK plc announced that the China National Medical Products Administration has approved Nucala (mepolizumab), as an add-on maintenance treatment for severe eosinophilic asthma in adults…
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Merck, known as MSD outside of the United States and Canada, and Harpoon Therapeutics, Inc. announced that the companies have entered into a definitive agreement under which Merck,…
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Johnson & Johnson announced it has entered into a definitive agreement to acquire Ambrx Biopharma, Inc., or Ambrx, a clinical-stage biopharmaceutical company with a proprietary…
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Boehringer Ingelheim and 3T Biosciences (“3T”) announced they have entered into a new strategic collaboration and licensing agreement focused on discovering and developing…
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AstraZeneca and Sanofi’s Beyfortus (nirsevimab), a long-acting monoclonal antibody, has been approved in China for the prevention of respiratory syncytial virus (RSV) lower respiratory…
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MediLink Therapeutics ("MediLink"), announced that it has entered into a worldwide collaboration and license agreement with Roche on the development of a next-generation antibody-drug…
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Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its marketing authorization application for the next-generation tyrosine kinase inhibitor (TKI)…
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GSK plc and Hansoh Pharma, a Chinese biopharmaceutical company committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders,…
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Roche announced that the U.S. Food and Drug Administration (FDA) has accepted, under Priority Review, the company’s supplemental Biologics License Application (sBLA) for Xolair…
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Merck, known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new Biologics License Application…
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Teva Pharmaceutical Industries Ltd. and Biolojic Design Ltd. ("Biolojic"), a biotechnology company that uses computational biology and artificial intelligence to transform antibodies…
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Alkermes plc announced that it has entered into a definitive agreement to sell its development and manufacturing facility in Athlone, Ireland to Novo Nordisk, a leading global…
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