Also known as: F.D.A., FDA, Food and Drug Administration, U.S. FDA, US FDA, USFDA, U.S. Food & Drug Administration, US Food & Drug Administration
BioNTech faces mixed analyst views as Bernstein initiates with a cautious Market Perform rating, while the company secures FDA Fast Track designation for BNT113 and prepares for a shareholder vote on capital restructuring and leadership transition.
Johnson & Johnson faces new talc verdicts in Minnesota and Pennsylvania totaling over $10 million, with 67,000+ lawsuits pending. Meanwhile, the FDA approved a new monthly dosing for RYBREVANT FASPRO, and the company launched its Shockwave C2 Aero coronary catheter globally.
FDA approves AstraZeneca and Daiichi Sankyo's Datroway for first-line TNBC patients not eligible for PD-1/L1 inhibitors, based on Phase III TROPION-Breast02 data showing a 21% reduction in risk of death versus chemotherapy.
A phase II trial of TAK-007 CAR-NK therapy in R/R B-cell NHL showed a 60.9% overall response rate. Preclinical CAR-NKT therapy eliminated endometrial tumors in models. Optimized costimulatory domains (2B4-DAP12) boosted CAR-NK tumor killing.
A comparative study found Canadian patients waited more than 90 weeks longer than Americans and 65 weeks longer than Europeans for new drugs approved between 2019 and 2025. The report said late submissions to Health Canada, along with price controls and other market factors, were the main drivers.
The FDA finalized a framework for reviewing food chemicals already on the market and launched assessments of BHT and ADA. Public comments on both reassessments are open until July 13, 2026.
The FDA has accepted Ascelia Pharma's NDA for Orviglance, a manganese-based oral MRI contrast agent for liver imaging in patients with severe kidney impairment, and set a PDUFA action date of July 3, 2026.
Acrivon Therapeutics said its wholly owned laboratory in Watertown received Massachusetts CLIA certification with a full license to conduct patient testing and develop companion diagnostics. The company said the lab is expected to be fully operational in the first half of 2026 and will support targeted therapeutics development.
Sentante secured CE-mark approval for its multi-domain robotic platform and was accepted into the FDA’s total product life cycle advisory programme. The moves support European commercialization and planning for remote stroke thrombectomy clinical studies.
The FDA approved Novocure’s Optune Pax, a wearable tumor-treating fields device, for pancreatic cancer in combination with chemotherapy. Phase III PANOVA-3 data showed delayed pain progression and improved one-year overall survival in inoperable locally advanced disease.
