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 ...

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.

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.

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.

The FDA wants to remove a limitation stating that the therapy's safety and effectiveness have not been established in men with age-related low testosterone ...

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.

In patients with 1 prior line of systemic therapy, the IB6-directed ADC showed favorable trends in both overall survival and progression free survival vs docetaxel.

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

Living guideline presents pharmacologic treatments that are recommended with lifestyle modifications for weight management.

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