Recent blog posts
Antengene Declares Phase I Trial for ATG-031, an Anti-CD24 Monoclonal Antibody
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Antengene Declares Phase I Trial for ATG-031, an Anti-CD24 Monoclonal Antibody
28 September 2023
Antengene Corp Ltd obtained approval from University of Texas MD Anderson Cancer Center's Institutional Review Board for a Phase I trial of its prime anti-CD24 antibody, ATG-031, focusing on advanced hematology and oncology solutions.
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Alvotech Gives U.S. Regulatory Progress Report on AVT02, a Humira® (adalimumab) Interchangeable Biosimilar Candidate with High Concentration
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Alvotech Gives U.S. Regulatory Progress Report on AVT02, a Humira® (adalimumab) Interchangeable Biosimilar Candidate with High Concentration
28 September 2023
Alvotech declared today that the U.S. FDA has agreed to Alvotech's revised BLA for AVT02.
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Vir Biotechnology reports first subject treated in fresh Phase 1 trial of VIR-1388, a potential T cell HIV prevention vaccine under study
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Vir Biotechnology reports first subject treated in fresh Phase 1 trial of VIR-1388, a potential T cell HIV prevention vaccine under study
28 September 2023
Vir Biotechnology, Inc. reports first participant dosed in Phase 1 trial evaluating safety, reactogenicity, and immunogenicity of VIR-1388.
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Hepagene Therapeutics Confirms FDA Approval of Experimental New Drug Application (IND) for HPG7233 THR Beta Stimulant
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Hepagene Therapeutics Confirms FDA Approval of Experimental New Drug Application (IND) for HPG7233 THR Beta Stimulant
28 September 2023
Hepagene Therapeutics revealed that its IND application forHPG7233 has been approved by the FDA in the United States.
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Sapience Therapeutics announces ST101 clinical results at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
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Sapience Therapeutics announces ST101 clinical results at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
27 September 2023
Sapience Therapeutics publicizes the demonstration of ST101 Clinical findings at the International Conference on Molecular Targets and Cancer Therapeutics held by AACR-NCI-EORTC in 2023.
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SpyBiotech reports submission of Clinical Trial Application to MHRA for SPYVLP01
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SpyBiotech reports submission of Clinical Trial Application to MHRA for SPYVLP01
27 September 2023
SpyBiotech has declared that they've submitted a clinical trial request to the U.K. MHRA for SPYVLP01 assessment.
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The FDA expedites reviewing Merck's request to use KEYTRUDA®, alongside chemoradiotherapy, for cervical cancer treatment
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The FDA expedites reviewing Merck's request to use KEYTRUDA®, alongside chemoradiotherapy, for cervical cancer treatment
27 September 2023
Merck has reported that the U.S. FDA is conducting a priority analysis on a fresh sBLA petitioning for authorization of KEYTRUDA, Merck’s anti-PD-1 treatment.
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The Menarini Group's ORSERDU® (Elacestrant) has received approval from the EC for breast cancer
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The Menarini Group's ORSERDU® (Elacestrant) has received approval from the EC for breast cancer
27 September 2023
The Menarini Group,together with their fully owned subsidiary Stemline Therapeutics Inc., declared that ORSERDU® (elacestrant) has received authorisation from the European Commission.
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Orchard Therapeutics Declares Approval of Biologics License Application for OTL-200 pertaining to MLD
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Orchard Therapeutics Declares Approval of Biologics License Application for OTL-200 pertaining to MLD
26 September 2023
Orchard Therapeutics, a renowned leader in gene therapy worldwide, reported that the U.S. FDA has approved the submission of their BLA for OTL-200.
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Rani Therapeutics begins Phase 1 trial of RT-111
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Rani Therapeutics begins Phase 1 trial of RT-111
26 September 2023
Rani Therapeutics Holdings proclaimed the launch of a Phase 1 clinical investigation assessing the safety and tolerability of RT-111.
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LAPIX Therapeutics Inc. reports FDA has approved their IND application for LPX-TI641, designed to treat for Multiple Sclerosis
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LAPIX Therapeutics Inc. reports FDA has approved their IND application for LPX-TI641, designed to treat for Multiple Sclerosis
26 September 2023
LAPIX Therapeutics, Inc. announced U.S. FDA clearance of its IND application. The approval enables Phase 1 trials for its leader compound, LPX-TI641, aimed at treating multiple sclerosis.
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Revolution Medicines initiates dosing in Phase 1/1b clinical study for RMC-9805, an orally administered, covalent, mutant-specific KRASG12D inhibitor
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Revolution Medicines initiates dosing in Phase 1/1b clinical study for RMC-9805, an orally administered, covalent, mutant-specific KRASG12D inhibitor
26 September 2023
Revolution Medicines, Inc. has initiated Phase 1/1b trials for RMC-9805, a covalent, oral KRAS G12D inhibitor for RAS-dependent cancers and the first patient already dosed targeting KRAS G12D mutation-driven cancers.
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