News

Umoja Biopharma, Inc. (Umoja), the clinical-stage leader of in vivo cell therapies that aim to realize the full reach and promise of CAR T cells, announced the closing of a $100 million…
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Solid Biosciences Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SGT-212 for the treatment of…
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Dizal, a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced that the U.S. Food and Drug Administration…
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Amgen announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorisation to IMDYLLTRA for the treatment of adult…
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Variant Bio, a genomics-driven drug discovery company, announced a multi-year research collaboration with Novo Nordisk to discover novel targets for the treatment of metabolic disease.…
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Tempest Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to amezalpat (TPST-1120), an oral, small molecule,…
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Sentynl Therapeutics, Inc. ("Sentynl"), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. ("Zydus Group"), and Fortress Biotech, Inc. ("Fortress")…
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Candid Therapeutics, Inc. (“Candid”), a clinical-stage biotechnology company focused on becoming the leader in advancing T-cell engagers for autoimmune and inflammatory diseases,…
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GSK plc announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for GSK5764227 (GSK’227), its B7-H3-targeted antibody-drug conjugate (ADC)…
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Ultragenyx Pharmaceutical Inc., a biopharmaceutical company focused on the development and commercialisation of novel therapies for rare and ultrarare genetic diseases, announced that…
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GSK plc announced that the China National Medical Products Administration has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as an add-on…
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LPOXY Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on innovative therapies for infectious disease prevention, announced that it has signed a term sheet to…
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Brii Biosciences Limited, a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet medical needs announced that it has entered…
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Astellas Pharma Inc. announced that China's National Medical Products Administration (NMPA) has approved VYLOY™ (zolbetuximab), in combination with fluoropyrimidine- and…
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Seres Therapeutics, Inc. (Seres or the Company) announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to SER-155, the Company’s lead…
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Santhera Pharmaceuticals announces that China’s National Medical Products Administration (NMPA) has approved AGAMREE (vamorolone) for use in China in patients aged 4 years and older.…
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Datopotamab deruxtecan (Dato-DXd) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of adult patients with locally advanced or metastatic epidermal…
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GSK plc announced the US Food and Drug Administration (FDA) has accepted for review, data from the MATINEE study to support the regulatory review process to obtain a new indication for…
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The US Food and Drug Administration has granted Fast Track designation to two Sanofi combination vaccine candidates to prevent influenza and COVID-19 infections in individuals 50 years…
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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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