CARY, N.C., Dec. 16, 2025 /PRNewswire/ -- InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its ...
Radiopharmaceutical therapy (RPT) offers molecular-targeted treatment strategies and presents an ideal model for advancing ...
For more than 15 years, Aldo Vidinha has worked at the intersection of engineering, quality, and regulatory strategy in the life sciences. His career has taken him across Europe, Asia, the United ...
In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...
The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...
A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and ...
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Diabeloop receives FDA 510(k) clearance for DBLG2, an Automated Insulin Delivery algorithm in an App
Diabeloop receives FDA 510(k) clearance for DBLG2, an Automated Insulin Delivery algorithm in an App: a strategic ...
New artificial intelligence-enabled health wearable devices and clinical decision support software will not face U.S. Food and Drug Administration regulatory ...
Holly™ by Nephrodite becomes the first device to achieve the designation, marking a major regulatory milestone toward first-in-human clinical studies Nephrodite, Inc., a medical device company ...
Over 1,200 new annual U.S. cases of osteosarcoma and Ewing sarcoma in patients under 20 (American Cancer Society, SEER estimates). Additional 2,600 primary bone cancer cases in young adults (20–39) ...
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