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CDER director Janet Woodcock discusses collaborative efforts to advance regulatory science.[ Price : $8.95]
An FDA study finds that Boehringer Ingelheim Pharmaceuticalss Pradaxa (dabigatran etexilate mesylate) was associated with reduced ...[ Price : $8.95]
FDA partially approves a 2011 Public Citizen petition calling on FDA to require labeling changes to all proton pump inhibitors.[ Price : $8.95]
A new RAND Corp. analysis says that biosimilar products have the potential to cut spending on biologics in the U.S. by $44 billion...[ Price : $8.95]
Richard-Allan Scientific begins a Class 1 recall of its 10% Neutral Buffered Formalin due to product concentration concerns.[ Price : $8.95]
FDA grants Astellas an orphan drug designation for isavuconazole and its use in treating invasive candidiasis.[ Price : $8.95]
FDA accepts for review a Boehringer Ingelheim NDA for Spiriva Respimat (tiotropium bromide) inhalation spray that is seeking an in...[ Price : $8.95]
In an unprecedented move, FDA issues a statement to clarify that data integrity or fraud is not at the center of why Sarepta Thera...