What’s New Trading partners and manufacturers can use the 3911 platform in FDA’s CDER NextGen Portal (CDER NextGen) to notify FDA of illegitimate products. Question 2 […]
Disappointing phase 3 trial results of a drug approved for the treatment of amyotrophic lateral sclerosis (ALS) may prompt the manufacturer to voluntarily pull it from […]
The US Food and Drug Administration (FDA) has put off a decision expected this month on whether to approve donanemab for Alzheimer’s disease (AD). Instead, the […]
A diagnostic approach that clusters multiple tests of visual field and retinal imaging in an intense 6-month period has demonstrated the potential to identify patients likely […]
Vitamin D levels are unlikely to have an impact on the clinical features of eosinophilic esophagitis (EoE) in adults newly diagnosed with the chronic inflammatory disorder, […]
TOPLINE: Children exposed to antibiotics during birth may have an increased risk of developing autoimmune diseases in childhood, research showed. METHODOLOGY: Researchers conducted a prospective study […]
As the world grappled with the challenges of the COVID-19 pandemic, telehealth emerged as a critical tool for delivering medical care while minimizing the risk for […]
The US Food and Drug Administration (FDA) has granted breakthrough designation to an LSD-based treatment for generalized anxiety disorder (GAD) based on promising topline data from […]
In the phase 3b ELEVATE trial, preventive treatment with atogepant (Qulipta) significantly reduced monthly migraine days compared to placebo in adults with episodic migraine in whom […]
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