FDA says it is asking the Model-Informed Drug Development meeting requests and packages to include a credibility framework.
The journal Nature explores researchers questions about how FDA will act on two new amyloid-β therapies for Alzheimers disease, given its experie...
Researchers say FDA and NIH could do more to enforce ClinicalTrials.gov reporting requirements.
FDA authorizes the de novo marketing of AppliedVRs EaseVRx, a prescription-use immersive virtual reality system that uses cognitive behavioral therapy...
FDA grants Medtronic 510(k) clearance for its PillCam Small Bowel 3 system for remote endoscopy procedures.
FDA warns Guyer Institute of Molecular Medicine about CGMP and other violations in its production of compounded drugs.
Pfizer says it will submit new data for its Covid-19 oral antiviral Paxlovid (ritonavir) that showed the drug significantly reduced hospitalization an...
Reps. Upton and DeGette introduce their bipartisan Cures 2.0 legislation to create an Advanced Research Projects Agency-Health to work on cures and tr...