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Astellas' Vyloy Approved in Europe as First-Line Treatment for CLDN18.2-Positive Gastric Cancer
The European Commission approval was based on two Phase III trials showing Vyloy plus chemo improved survival outcomes versus chemo alone.
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AstraZeneca, Daiichi Sankyo Hoping to Sway FDA of Dato-DXd Benefit Despite Overall Survival Miss
Despite showing a progression-free survival benefit, the antibody-drug conjugate did not improve overall survival in HR-positive, HER2-negative or -low breast cancer.
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Sensorion Doses First Patient in Phase I/II Trial of OTOF-Linked Hearing Loss Gene Therapy
NEW YORK – Sensorion on Monday said that by year end it expects to complete dosing the first cohort of pediatric patients with congenital hearing loss with its gene therapy candidate SENS-501 in the ...
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Achilles Therapeutics Shuts Down Engineered Cell Therapy Program, Explores Cost-Cutting Measures
The firm is discontinuing its CHIRON and THETIS trials after lackluster data and is planning for potential third-party deals and workforce layoffs.
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Janssen's Rybrevant, Chemo Regimen Nets FDA Approval in EGFR-Mutated NSCLC
The agency reviewed data from the MARIPOSA-2 trial and approved the regimen for patients with common EGFR mutations who are progressing on EGFR inhibitors.
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Family Heart Foundation Implementing Machine-Learning Tool for Identifying Patients With High Lp(a)
A group of hospital systems are using the machine-learning model to guide decisions on who should be tested for high levels of lipoprotein(a).