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Solid Biosciences Receives FDA IND Clearance for Dual Route Gene Therapy in Friedreich’s Ataxia

Jan 8, 2025
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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FDA Granted Priority Review to Dizal’s Sunvozertinib New Drug Application

Jan 8, 2025
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’s IMDYLLTRA Granted Conditional Approval for Small Cell Lung Cancer in UK

Jan 8, 2025
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 Partners with Novo Nordisk to Discover Metabolic Disease Targets

Jan 8, 2025
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 Receives Orphan Drug Designation for Amezalpat in HCC Treatment

Jan 8, 2025
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 Announces FDA Acceptance and Priority Review of CUTX-101 for Menkes Disease

Jan 8, 2025
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 Enters into Agreement with WuXi Biologics on Trispecific T-cell Engager

Jan 8, 2025
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’s B7-H3-targeted antibody-drug conjugate, GSK’227, receives US FDA Breakthrough Therapy…

Jan 8, 2025
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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European Commission (EC) Extends the Approval of Evkeeza (evinacumab) to Children as Young as…

Jan 7, 2025
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’s Nucala (mepolizumab) approved in China for treatment of adults with chronic rhinosinusitis…

Jan 7, 2025
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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