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Jacobus Pharmaceutical recalls three lots of Ruzurgi (amifampridine) 10 mg tablets due to potential contamination with yeast, mold...[ Price : $8.95]
FDA clears an inTravent Medical Partners 510(k) for the SoloPass system for aiding in the frontal placement of intra-ventricular c...[ Price : $8.95]
Federal Register notice: FDA consolidates regulatory oversight responsibilities in CBER for certain devices, and accordingly fat t...[ Price : $8.95]
FDA posts a draft International Conference for Harmonization guideline entitled Nonclinical Biodistribution Considerations For Gen...[ Price : $8.95]
FDA classifies as Class 1 an Eco-Med Pharmaceutical recall of all ultrasound gels and lotions manufactured by the company (XXX SUB...[ Price : $8.95]
FDA accepts for review a BeiGene BLA for its anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurre...[ Price : $8.95]
Federal Register notice: FDA withdraws three NDAs because the application holders have repeatedly failed to file required annual r...[ Price : $8.95]
A Lancet article authored by two retiring senior FDA vaccine officials and other researchers argues against requiring Covid-19 boo...