News | November 30, 2025
a2z wins FDA nod for groundbreaking abdomen-pelvis CT AI Triage system
Abdomen-pelvis CT is the nation’s highest-volume CT category
Abdomen-pelvis CT is the nation’s highest-volume CT category
RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA submission and commercialization of the product in the US
The update reflects long-term clinical trial data showing that many patients with mCSCC or laCSCC experienced lasting responses
Itvisma is a one-time, fixed-dose therapy designed to tackle the genetic root cause of SMA
The study successfully met its primary endpoint, demonstrating similar rates of viral suppression for DOR/ISL compared to Biktarvy at 48 weeks
HER2-mutant NSCLC typically has a poor prognosis and limited treatment options
The upcoming facility marks a strategic milestone in SOUKYA’s mission to make evidence-based holistic healthcare
The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases
Orphan drug designation (ODD) by the USFDA for Desidustat, provides eligibility for a potential seven-year marketing exclusivity subject to the USFDA approval
FDA authorization was based on two years of clinical study data demonstrating that Essilor Stellest lenses significantly slowed myopia progression compared to single-vision control lenses
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