FDA has issued a draft guidance for industry that provides recommendations to sponsors about using minimal residual disease and complete response as primary endpoints in trials evaluating drugs and biologics intended to treat patients with multiple myeloma to support approval under the accelerated approval regulations.
Personalis announced the early access launch of Real-Time Variant Tracker, a powerful new option added to its ultrasensitive NeXT Personal molecular residual disease test designed to detect small traces of circulating tumor DNA in the blood that represent residual or recurrent cancer.
FDA accepted the new drug application for pimicotinib (ABSK021) as a systemic treatment for patients with tenosynovial giant cell tumor.
Cellares and City of Hope announced a collaboration to evaluate automated manufacturing of City of Hope’s investigational gene-modified CAR T-cell therapy targeting glioblastoma multiforme, an aggressive solid tumor brain cancer with limited treatment options.
Verana Health and COTA Inc. are merging with the aim of providing data and software solutions for real-world insights that accelerate clinical research, expedite treatment options, and improve patient care.
The University of Arkansas for Medical Sciences Winthrop P. Rockefeller Cancer Institute has fully implemented the Advarra OnCore Clinical Trials Management System, an investment that strengthens oversight, efficiency, and growth of cancer clinical trials.
FDA approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously administered therapy for patients with epidermal growth factor receptor-mutated non-small cell lung cancer.
FDA granted breakthrough therapy designation to Enhertu (trastuzumab deruxtecan) for adult patients with HER2-positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment and high risk of disease recurrence.
The China National Medical Products Administration approved pimicotinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause functional limitation or relatively severe morbidity.
Dark Blue Therapeutics was acquired by Amgen.
