The FDA has extended its review of the ProSense cryoablation system for early-stage breast cancer, with a decision expected ...
The FDA has granted approval to an act of compassionate use treatment with the anti-cancer drug Namodenoson for a patient ...
The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...
The FDA told staff on Monday that reviewers of medical products and inspectors of manufacturing facilities cannot take the ...
The US Food and Drug Administration (FDA) has identified a limited number of benzoyl peroxide (BPO) acne products for retail-level recall because of elevated benzene levels, but more than 90% of ...
Regulators are expected to make a decision in the third quarter of 2025 on Kerendia to treat patients with heart failure with ...
The FDA has approved Keytruda plus chemotherapy in HER2+ gastric or GEJ adenocarcinoma with PD-L1–positive expression, based on KEYNOTE-811 data.