News

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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Takeda announced that it has entered into an exclusive licensing agreement with Keros Therapeutics, Inc. to further develop, manufacture and commercialize elritercept worldwide outside…
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Maze Therapeutics, a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal,…
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Novartis announced that it has entered into a global license and collaboration agreement with PTC Therapeutics for PTC518, an HTT mRNA splice modulator with the potential to become the…
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Johnson & Johnson announced the submission of two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA…
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Valneva SE, a specialty vaccine company, announced that it has submitted a label extension application to the U.S. Food and Drug Administration (FDA) to potentially extend the use of…
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Acadia Pharmaceuticals Inc. announced it has entered into an exclusive worldwide license agreement with Saniona for the development and commercialization of SAN711, a first-in-class,…
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Roche announced today that it has entered into a definitive merger agreement to acquire Poseida Therapeutics, Inc., a public clinical-stage biopharmaceutical company pioneering…
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Sarepta Therapeutics, Inc. announced an exclusive global licensing and collaboration agreement with Arrowhead Pharmaceuticals, Inc. Sarepta will obtain exclusive global rights to…
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Adragos Pharma, a global pharmaceutical contract development and manufacturing organization (CDMO) headquartered in Munich, Germany, has acquired Baccinex, a Swiss-based expert in…
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Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s supplemental New…
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Eton Pharmaceuticals, Inc. an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, announced that it has acquired the U.S. rights to…
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