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FDA approves a Genentech supplemental NDA for Xofluza (baloxavir marboxil) for treating acute, uncomplicated influenza in people 1...[ Price : $8.95]
Viatrexx Bio recalls all products in 10 mL sterile injectable vials because they were manufactured in a manner that cannot guarant...[ Price : $8.95]
An FDA advisory committee votes 14 to 2 to recommend approval of a Shionogi NDA for cefiderocol injection for its proposed indicat...[ Price : $8.95]
Ipsen asks FDA to require in vivo bioequivalence for any ANDA citing its Somatuline Depot as the reference-listed drug.[ Price : $8.95]
FDA clears a Fidmi Medical 510(k) for its low-profile enteral feeding device.[ Price : $8.95]
Greenleaf Health adds good clinical practice services to its range of FDA regulatory consulting.[ Price : $8.95]
FDA grants Cleveland Diagnostics a breakthrough device designation for the IsoPSA Assay, a prostate cancer diagnostic test.[ Price : $8.95]
Federal Register notice: FDA requests nominations for a nonvoting representative to serve on the Tobacco Products Scientific Advis...