FDA grants priority review to Enhertu for high-risk HER2-positive breast cancer
Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population
Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population
Built on the Percept Platform and enhanced with BrainSense technology, the system can adjust stimulation levels in real time, responding to brain signals without manual intervention
SYNT-101 is a once-daily oral pill engineered to redirect nutrient absorption beyond the small intestine’s duodenum
The move follows encouraging Phase I data and a series of regulatory wins from the U.S. Food and Drug Administration
The drug’s safety profile in LIBRETTO-432 aligned with previous selpercatinib studies, showing no unexpected concerns
The approval is based on the SWIFT and ANCHOR phase III trials, which demonstrated sustained efficacy with a twice-yearly dosing regimen
The trial, which compared Retevmo to placebo, met its primary endpoint with a “highly statistically significant and clinically meaningful improvement” in investigator-assessed EFS for patients with stage II–IIIA disease
PreemieFort Enteral Solution's approval marks the first time a nutritional product derived from human milk has been recognized as a prescription medicine anywhere in the world
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