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Human Drugs

Scientists Ask How FDA Will Review New Alzheimer Drugs

The journal Nature explores researchers questions about how FDA will act on two new amyloid-β therapies for Alzheimers disease, given its experie...

Human Drugs

Improve FDA ClinicalTrials.gov Enforcement: Researchers

Researchers say FDA and NIH could do more to enforce ClinicalTrials.gov reporting requirements.

Medical Devices

De Novo Granted for Virtual Reality for Pain

FDA authorizes the de novo marketing of AppliedVRs EaseVRx, a prescription-use immersive virtual reality system that uses cognitive behavioral therapy...

Medical Devices

Medtronic PillCam At-Home Endoscopy

FDA grants Medtronic 510(k) clearance for its PillCam Small Bowel 3 system for remote endoscopy procedures.

Human Drugs

Multiple Violations at Guyer Institute

FDA warns Guyer Institute of Molecular Medicine about CGMP and other violations in its production of compounded drugs.

Human Drugs

Pfizer Covid Pill Reduces Hospitalization/Death: Study

Pfizer says it will submit new data for its Covid-19 oral antiviral Paxlovid (ritonavir) that showed the drug significantly reduced hospitalization an...

Human Drugs

Upton, DeGette Introduce Cures 2.0

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...

Human Drugs

PhRMA Strategies to Enhance Trial Diversity

PhRMA and Deloitte release a report with strategies for increasing clinical trial diversity.

Federal Register

FDA Terminates Kalidindi Debarment

Federal Register notice: FDA issues an order granting special termination of the debarment involving Sanyasi Raju Kalidindi.

Federal Register

Qinlock Regulatory Review Period Determined

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Deciphera Pharmaceuticals Qinlock (ripretinib),...