FDA elevated OS Therapies' Type D meeting to Type B pre-BLA meeting for OST-HER2 in osteosarcoma, signaling transition to Accelerated Approval discussions. Clinical data submission targeted for end of Q1 2026.
At least 111 substances of unknown safety have been added to U.S. foods, drinks and supplements without alerting the FDA, exploiting a legal loophole in the "generally recognized as safe" standard, according to a new investigation.
Trader Joe's recalled chicken fried rice nationwide due to possible glass contamination after four customer reports. Separately, the FDA expanded a recall of McCain Foods tater tots to 648,000 pounds over plastic fragment concerns.
F3 Tech will lead Maryland's proposal for a $40 million multi-user biomanufacturing facility under the federal BioMADE program, developed with the Maryland Department of Commerce to strengthen the state's biotechnology economy.
California-based Centivax has begun dosing participants in a Phase 1A clinical trial of Centi-Flu 01, a universal influenza vaccine designed to target conserved viral regions across all flu strains. Initial data from approximately 180 participants is expected within the year.
The FDA announced a full reassessment of butylated hydroxyanisole (BHA), a chemical preservative used in packaged foods, to determine if it remains safe based on current science. The review follows decades of concerns about BHA being listed as "reasonably anticipated to be a human carcinogen."