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EMA Accepts Marketing Submission for AVT06, an Aflibercept Biosimilar to Eylea®
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EMA Accepts Marketing Submission for AVT06, an Aflibercept Biosimilar to Eylea®
19 August 2024
Alvotech declared that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech’s planned biosimilar to Eylea® (aflibercept).
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CV6 Therapeutics Begins Dosing Patients in Phase 1a Trial for Novel dUTPase Inhibitor CV6-168
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CV6 Therapeutics Begins Dosing Patients in Phase 1a Trial for Novel dUTPase Inhibitor CV6-168
19 August 2024
CV6 Therapeutics has reported the successful administration of the second patient in its Phase 1a clinical trial assessing CV6-168 in combination with infusional 5-fluorouracil (5-FU) for cancer treatment.
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UroGen Submits UGN-102 NDA, Targets FDA Approval for Intermediate-Risk Bladder Cancer Treatment
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UroGen Submits UGN-102 NDA, Targets FDA Approval for Intermediate-Risk Bladder Cancer Treatment
15 August 2024
UroGen Submits NDA for UGN-102, Aiming for FDA Approval as the First Treatment for Intermediate-Risk, Low-Grade Non-Muscle Invasive Bladder Cancer.
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Verrica Pharmaceuticals Presents Positive Early Data from Phase 2 of VP-315 Basal Cell Carcinoma Treatment Study
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Verrica Pharmaceuticals Presents Positive Early Data from Phase 2 of VP-315 Basal Cell Carcinoma Treatment Study
15 August 2024
Verrica Pharmaceuticals Reveals Encouraging Initial Topline Data from Phase 2 Study Part 2 of VP-315, an Experimental Oncolytic Peptide Immunotherapy for Basal Cell Carcinoma Treatment.
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ACELYRIN, INC. Shares Encouraging Phase 3 Results for Izokibep in Hidradenitis Suppurativa
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ACELYRIN, INC. Shares Encouraging Phase 3 Results for Izokibep in Hidradenitis Suppurativa
15 August 2024
ACELYRIN revealed that the Phase 3 trial of izokibep for Hidradenitis Suppurativa (HS) successfully met its primary endpoint of HiSCR75 at the 12-week mark.
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Bavarian Nordic's Chikungunya Vaccine BLA Accepted and Granted Priority Review by FDA
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Bavarian Nordic's Chikungunya Vaccine BLA Accepted and Granted Priority Review by FDA
15 August 2024
Bavarian Nordic A/S (OMX: BAVA) announced today that the U.S. FDA has accepted and given Priority Review status to the Biologics License Application (BLA) for CHIKV VLP(PXVX-0317).
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Galderma Gets U.S. FDA Nod for Nemluvio® (nemolizumab) to Treat Adult Prurigo Nodularis
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Galderma Gets U.S. FDA Nod for Nemluvio® (nemolizumab) to Treat Adult Prurigo Nodularis
15 August 2024
Galderma has revealed that the U.S. FDA has given the green light to Nemluvio® (nemolizumab) as a pre-filled pen designed for subcutaneous injection to treat adults suffering from prurigo nodularis.1.
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The FDA Grants Approval for Biosyngen’s BRG01 to Begin Phase II Clinical Trial
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The FDA Grants Approval for Biosyngen’s BRG01 to Begin Phase II Clinical Trial
15 August 2024
Biosyngen is excited to share that the U.S. Food and Drug Administration (FDA) has given the green light for its BRG01, an EBV-specific CAR-T cell therapy.
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VISEN Pharmaceuticals' Phase 3 Trial of Palopegteriparatide Successfully Meets Major Goals in Treating Hypoparathyroidism
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VISEN Pharmaceuticals' Phase 3 Trial of Palopegteriparatide Successfully Meets Major Goals in Treating Hypoparathyroidism
14 August 2024
VISEN Pharmaceuticals reported that the Phase 3 PaTHway China Trial of Palopegteriparatide met its main and key secondary goals in treating adults with hypoparathyroidism.
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Kyverna Therapeutics gets FDA RMAT status for KYV-101 to treat progressive myasthenia gravis
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Kyverna Therapeutics gets FDA RMAT status for KYV-101 to treat progressive myasthenia gravis
14 August 2024
Kyverna Therapeutics' KYV-101 Granted RMAT Designation by FDA for Progressive Myasthenia Gravis Treatment.
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First Patient Dosed in Phase 2 Anti-TIGIT Therapy Trial for Advanced Liver Cancer
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First Patient Dosed in Phase 2 Anti-TIGIT Therapy Trial for Advanced Liver Cancer
14 August 2024
Initial Patient Administered in Phase 2 Study of New Anti-TIGIT Fc Fusion Protein with Serplulimab and HANBEITAI for First-line Therapy in Advanced Hepatocellular Carcinoma.
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Pfizer Reveals Key Findings of ABRYSVO® for RSV in Adults with Compromised Immunity
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Pfizer Reveals Key Findings of ABRYSVO® for RSV in Adults with Compromised Immunity
14 August 2024
This research is assessing the administration of two doses of the ABRYSVO vaccine in immunocompromised adults aged 18.
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