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...
Federal Register notice: FDA seeks comments on an information collection extension entitled Financial Disclosure by Clinical Investigators.
Federal Register notice: FDA renews its Patient Engagement Advisory Committee for an additional two years beyond the charter expiration date.
FDA approves Janssens Darzalex Faspro plus Kyprolis and dexamethasone to treat some multiple myelomas.