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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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Pilatus Biosciences Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its leading molecule, PLT012, for treating liver and…
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Ipsen and Biomunex Pharmaceuticals announced an exclusive global licensing agreement for BMX-502. BMX-502 is a bispecific antibody that engages and activates a subset of cytotoxic T…
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Eli Lilly and Company announced topline results from the SURMOUNT-5 phase 3b open-label randomized clinical trial. Zepbound (tirzepatide) provided a 47% greater relative weight loss…
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