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Regeneron calls on FDA to develop two guidances to further the use of precision medicine in non-oncology diseases.[ Price : $8.95]
Glenmark Pharmaceuticals recalls (Class 1) 114 batches of potassium chloride extended-release capsules, USP (750 mg), due to disso...[ Price : $8.95]
A House subcommittee report claims that FDA cut corners in its usually rigorous processes and bowed to Biden Administration politi...[ Price : $8.95]
FDA releases a guidance entitled Laboratory Developed Tests: Small Entity Compliance Guide.[ Price : $8.95]
FDA approves an Endotronix PMA for its Cordella Pulmonary Artery Sensor System for treating New York Heart Failure Class III heart...[ Price : $8.95]
The House Energy and Commerce Committee seeks additional inspection records from FDA after its analysis of the foreign drug inspec...[ Price : $8.95]
FDA denies a 4/2023 petition that called on the agency to withdraw approval for Harmony Biosciences Wakix (pitolisant) and take ot...[ Price : $8.95]
FDA approves Halozyme Therapeutics Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for treating chronic inflammatory de...