FDA issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the level of nicotine in those products. If finalized, the United States would be the first country globally to take such a bold, life-saving action to prevent and reduce smoking-related disease and death.
FDA is revoking the authorization for the use of FD&C Red No. 3 as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. FDA is amending its color additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition.
FDA granted Rare Pediatric Disease designation for THIO in pediatric-type diffuse high-grade gliomas.
N-Power Medicine announced the acquisition of Syapse Holdings Inc. The integration of Syapse into N-Power Medicine incorporates Syapse’s network of community-based health systems, with more than 1,000 oncologists, its data and technology stack, and its team.
MAIA Biotechnology Inc. and BeiGene entered into a clinical supply agreement to assess the efficacy of THIO, MAIA Biotechnology’s small molecule telomere-targeting anticancer agent, in combination with BeiGene’s immune checkpoint inhibitor tislelizumab, in three cancer indications. The single-arm pivotal phase II trials will study the drug combination in hepatocellular carcinoma, small cell lung cancer, and colorectal cancer.
Caris Life Sciences and Ontada announced a strategic and multi-faceted collaboration to advance molecular research and cancer care, enhance the healthcare delivery system and ultimately drive precision medicine by supporting life sciences companies in the development of next-gen oncology therapies.
FDA issued a draft guidance with the Office for Human Research Protections that, when finalized, will provide recommendations for including tissue biopsies as part of clinical trials.
FDA approved Ensacove (ensartinib) for adult patients with anaplastic lymphoma kinase-positive locally advanced or metastatic non-small cell lung cancer who have not previously received an ALK-inhibitor.
FDA approved Tevimbra (tislelizumab-jsgr) in combination with platinum and fluoropyrimidine-based chemotherapy for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1 (≥1).
FDA approved Unloxcyt (osibelimab-ipdl), a programmed death ligand-1 blocking antibody, for adults with metastatic cutaneous squamous cell carcinoma or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
