TLX007-CDx is a cold kit designed for the preparation of PSMA-targeted PET imaging for prostate cancer. It leverages ...

The FDA has extended its review of the ProSense cryoablation system for early-stage breast cancer, with a decision expected ...

Encelto is small, semi-permeable capsule implanted in the eye that contains allogeneic retinal pigment epithelium cells ...

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The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...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 has approved Keytruda plus chemotherapy in HER2+ gastric or GEJ adenocarcinoma with PD-L1–positive expression, based on KEYNOTE-811 data.

The Department of Government Efficiency has cut staff at the Food and Drug Administration, including employees in food safety roles.

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 set a PDUFA target action date of October 23, 2025, for the low-dose atropine formulation.

Moon Surgical, a French-American pioneer in surgical innovation, announced today the United States Food and Drug ...

The FDA first approved eculizumab for use in adult patients with generalized myasthenia gravis in 2017, before expanding the ...