Pfizer and BioNTech say they have formally submitted an emergency use authorization request for their mRNA Covid-19 vaccine and its use in children ag...
FDA reclassifies surgical staplers for internal use from Class 1 to Class 2 and delays enforcement of the change for 180 days.
NeuroMetrix submits a de novo request for its Quell wearable neuromodulation device for treating symptoms of fibromyalgia in adults.
FDA issues a revised draft guidance on drug compounding by hospital and health system pharmacies.
FDA raises issues to be resolved in a complete response letter to a Polarean Imaging NDA for a drug-combination product to enhance MRI imaging in pulm...
Federal Register notice: FDA makes available a final guidance entitled #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of...
Federal Register notice: FDA makes available a final guidance entitled #265 Use of Data from Foreign Investigational Studies to Support Effectiveness ...
Cassava Sciences says it is opening its first of two Phase 3 efficacy studies of simufilam for use in patients with mild to moderate Alzheimers diseas...