FDA accepted the supplemental Biologics Application for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage 2A to 3B non-small cell lung cancer. FDA assigned a Prescription Drug User Fee Act goal date of Oct. 8.
Friends of Cancer Research initiated a new research partnership, Digital and Computational Pathology Tool Harmonization, or Digital PATH, Project. The project will identify factors that may contribute to variability in biomarker assessment across computational pathology platforms, propose areas for alignment in the field, and provide insights for shaping regulatory processes.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended marketing authorization approval of Abecma (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
The European Commission has granted marketing authorization for Omjjara (momelotinib), a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor. Omjjara is the first authorized medicine in the EU for disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with moderate to severe anemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or... […]
FDA approved Balversa (erdafitinib) for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy.
Tempus has added a novel MRD assay, xM, to its testing solutions.
FDA approved Keytruda (pembrolizumab) with chemoradiotherapy for patients with FIGO 2014 stage 3-4A cervical cancer.
The United States Patent and Trademark Office, or USPTO issued U.S. Patent No. US 11,873,348 covering ATOR-4066, a Neo-X-Prime next generation bispecific antibody targeting CD40 and CEACAM5, in the treatment of cancer.
Caris Life Sciences and Flatiron Health have partnered to create a multimodal data offering to support and accelerate biopharmaceutical drug development and patient care.
Veracyte, a global cancer diagnostics company, has acquired C2i Genomics, a company combining genomics and AI to create a whole-genome cancer intelligence platform.
