Pharma Journalist -

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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