Targeted Oncology4h
FDA Updates Decision on ProSense Cryoablation for Early-Stage Breast Cancer
The FDA has extended its review of the ProSense cryoablation system for early-stage breast cancer, with a decision expected ...
CURE1d
FDA Grants Compassionate Use Treatment to Namodenoson in Pancreatic Cancer
The FDA has granted approval to an act of compassionate use treatment with the anti-cancer drug Namodenoson for a patient ...
PharmExec9d
FDA’s New Accelerated Approval Draft Guidance
The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...
Medscape2d
FDA Confirms Low Benzene Levels in Most BPO Products Tested
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 ...
Targeted Oncology1d
FDA Backs Phase 3 Trial of Pro-ocular for Ocular GVHD Treatment
Signal12 Pharmaceuticals has aligned with the FDA on its phase 3 clinical trial strategy for Pro-ocular, a novel drop-free ...
Managed Healthcare Executive3d
FDA Grants Priority Review to Kerendia in Heart Failure
Regulators are expected to make a decision in the third quarter of 2025 on Kerendia to treat patients with heart failure with ...
CURE1d
FDA Approves Keytruda in HER2+ Gastric, Gastroesophageal Junction Cancer
The FDA has approved Keytruda plus chemotherapy in HER2+ gastric or GEJ adenocarcinoma with PD-L1–positive expression, based on KEYNOTE-811 data.