Backed by phase 3 PATINA trial data, Ibrance is the first and only CDK4/6 inhibitor available for HR+ metastatic disease across all HER2 patient profiles.

HealthDay News — Clover Hill Dairy is recalling all of its brand cheese over possible Listeria contamination tied to a ...

Transitioning from accelerated to traditional status, the FDA's decision expands eligibility for the first solid-tumor engineered T cell therapy to include adolescents aged 12 and older.

The FDA has designated the filing as a complete, Class 1 response with a PDUFA target action date of August 2, 2026. The Food and Drug Administration (FDA) has accepted for review Replimune’s ...

Saliency-based score highlighted biologically meaningful regions, especially the optic nerve head and retinal vasculature.

Rifapentine is a cyclopentyl rifamycin antimycobacterial agent indicated for the treatment of active pulmonary tuberculosis and late tuberculosis infection.

Anti-VEGF injection followed by dexamethasone intravitreal implant showed noninferior efficacy to conventional treatment regimen ...

Trodelvy is now FDA-approved for first-line treatment of advanced TNBC, significantly improving PFS in phase 3 trials.

Tryngolza (olezarsen) is the first approved therapy to significantly lower acute pancreatitis events alongside robust triglyceride reductions in adults with severe hypertriglyceridemia.

The novel topical gel, designed to clear mutant keratin aggregates and restore intermediate filament network integrity via autophagy, is undergoing evaluation in the phase 2 TAMES-02 trial.

Although not bound by the panel's recommendations, the FDA takes them into consideration when reviewing the Biologics License Application. The Food and Drug Administration’s (FDA) Vaccines and Related ...