The FDA has granted Priority Review, setting a target decision date of 9 October 2026, potentially accelerating access to a new treatment option for a subset of patients with high-risk colon cancer characterized
The filing is backed by positive Phase 3 results recently published in JAMA Neurology
The backing comes as influenza remains a persistent public health burden
After a volatile decade in which approvals swung sharply from year to year, 2025’s total pushed past long-term norms, exceeding the 10-year average
The safety profile of the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines
The expanded approval covers children and teens with chronic conditions that increase vulnerability to pneumococcal infections
Company becomes sole first applicant for 45 mg strength, positioning itself for potential 180-day generic exclusivity in the US market
Study will assess the safety and effectiveness of irreversible electroporation as a minimally invasive treatment option for benign prostatic hyperplasia (BPH)
The newly approved treatment, SKINVIVE by JUVÉDERM, is now the first and only hyaluronic acid injectable cleared specifically for improving neck appearance
Expanded indication makes Stelo the first FDA-cleared OTC CGM for children aged two years and older with diabetes or prediabetes
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