A CDER executive tells a hemp industry conference that FDA still needs more information before it can address the use of CBD in food and dietary suppl...
The Justice Department says two former Immunomedics officials have been arrested on charges of insider trading.
FDA clears a CoreLink 510(k) for its CentraFix Midline Spinal Fixation System.
FDA clears a Sound Life Sciences 510(k) for its sonar software for consumer smart devices for measuring breathing.
Federal Register notice: FDA withdraws approval of five ANDAs from multiple applicants because they are no longer marketed.
FDA accepts for review a Merck supplemental BLA for Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for preventing invasive pneumococcal diseas...
FDA tells BeyondSpring Pharmaceuticals a second study is needed to demonstrate substantial benefit of its plinabulin in preventing chemotherapy-induce...
Federal Register notice: FDA classifies isocapnic ventilation devices into Class 2 (special controls), following a de novo classification request from...