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 ...

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 ...

BrainSpace announced that the FDA granted 510(k) clearance for its Intellidrop automated brain fluid management system.

Six days after a senior FDA official sent a sweeping internal email claiming that COVID-19 vaccines had caused the deaths of "at least 10 children," 12 former FDA commissioners released an ...

Swedish neurotech startup Flow Neuroscience has secured FDA approval for the first brain stimulation device for home use in ...

Here are 40 spine devices and technologies earning FDA clearances in 2025. Note: This is not an exhaustive list. 1. SurGenTec earned FDA 510(k) clearance for its OsteoFlo HydroFiber to be used as a ...

A major update to federal women’s health preventive guidance will make it easier for women to get screened for cervical ...

Stereotaxis plans to launch the MAGiC cardiac ablation catheter in early 2026, CEO and Chair David Fischel tells MassDevice.