Jacobus Pharmaceutical recalls three lots of Ruzurgi (amifampridine) 10 mg tablets due to potential contamination with yeast, mold, and aerobic bacter...
FDA clears an inTravent Medical Partners 510(k) for the SoloPass system for aiding in the frontal placement of intra-ventricular catheters.
Federal Register notice: FDA consolidates regulatory oversight responsibilities in CBER for certain devices, and accordingly fat transfer devices with...
FDA posts a draft International Conference for Harmonization guideline entitled Nonclinical Biodistribution Considerations For Gene Therapy Products I...
FDA classifies as Class 1 an Eco-Med Pharmaceutical recall of all ultrasound gels and lotions manufactured by the company (XXX SUBSTITUTE XXX) due to ...
FDA accepts for review a BeiGene BLA for its anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurrent locally advanced ...
Federal Register notice: FDA withdraws three NDAs because the application holders have repeatedly failed to file required annual reports.
A Lancet article authored by two retiring senior FDA vaccine officials and other researchers argues against requiring Covid-19 booster shots until dat...