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China’s NMPA Approves VYLOY (zolbetuximab) for First-Line Treatment of Advanced Gastric or…

Jan 6, 2025
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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FDA Grants Breakthrough Therapy Designation to Seres Therapeutics’ SER-155 for Bloodstream…

Dec 12, 2024
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 Gets NMPA Approval for AGAMREE (Vamorolone) in Duchenne Muscular Dystrophy

Dec 12, 2024
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 granted breakthrough therapy designation in US for patients with previously…

Dec 12, 2024
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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FDA accepts GSK’s submission for the use of Nucala (mepolizumab) in COPD

Dec 12, 2024
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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Two combination vaccine candidates for prevention of influenza and COVID-19 granted Fast Track…

Dec 12, 2024
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 and Kodiak Sciences Partner on Next-Gen Ophthalmic Antibody Therapies

Dec 12, 2024
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 Receives FDA Orphan Drug Designation for PLT012 in Liver Cancer

Dec 12, 2024
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 announce exclusive global licensing agreement for first-in-class MAIT cell…

Dec 5, 2024
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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Lilly’s Zepbound (tirzepatide) superior to Wegovy (semaglutide) in head-to-head trial showing…

Dec 5, 2024
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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Industry Reports

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Takeda Expands Entyvio Options Through Halozyme Technology…

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Press Releases

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From Innovation to Acquisition: CrossBridge Bio’s ADC…

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