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FDA releases its latest batch of Warning Letters that includes Premium Production and Results RNA.[ Price : $8.95]
FDA says it is confidence that AveXis Zolgensma should remain on the market despite manufacturer reports of a data manipulation pr...[ Price : $8.95]
Three stakeholders suggest changes to an FDA draft guidance on clinical trial diversity enhancement.[ Price : $8.95]
Federal Register notice: FDA announces the rates for biosimilar user fees for fiscal year 2020.[ Price : $8.95]
A California federal court allows an amended complaint by Pharmaceutical Research and Manufacturers of America against a Californi...[ Price : $8.95]
AbbVie files an NDA for elagolix, an oral gonadotropin-releasing hormone antagonist with a proposed indication for managing heavy ...[ Price : $8.95]
A JAMA viewpoint says legislation is needed to codify changes FDA is seeking to its medical device 510(k) program to reduce the re...[ Price : $8.95]
Foamix Pharmaceuticals files an NDA seeking approval for FMX103 foam for treating moderate-to-severe papulopustular rosacea in pat...