FDA has granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that can help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers.Â
FDA has accepted for priority review the Biologics License Application for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies.Â
FDA proposed a rule seeking to amend FDA’s regulations to make explicit that in vitro diagnostic products are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory.Â
FDA is taking steps to help further accelerate the development of novel drug and biological products for rare diseases.Â
FDA has approved Bosulif (bosutinib) for pediatric patients ages one year and older with chronic phase (CP) Ph+ chronic myelogenous leukemia (CML) that is newly diagnosed or resistant or intolerant (R/I) to prior therapy.Â
FDA has cleared the B·R·A·H·M·S CgA II Kryptor immunoassay to assess tumor progression in gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients.Â
FDA has granted Fast Track designation to Mythic’s investigational cMET-targeting ADC, MYTX-011, for the treatment of patients with non-small cell lung cancer with cMET overexpression.Â
Pierre Fabre Laboratories and Vernalis, a fully owned subsidiary of HitGen Inc., established a long-term partnership to identify pre-clinical candidates against oncology targets.
Mission Bio has developed a single-cell measurable residual disease assay that aims to advance personalized healthcare for patients with blood cancer.
FDA has approved Ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythemia), in adults with anemia.Â
