Targeted Oncology7h
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FDA’s New Accelerated Approval Draft Guidance
The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...
Endpoints News10d
Ex­clu­sive: FDA blocks drug and de­vice re­view­ers from tak­ing HH­S' buy­out of­fer
The FDA told staff on Monday that reviewers of medical products and inspectors of manufacturing facilities cannot take the ...
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 ...
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.