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FDA awards 15 grants totaling more than $14 million to boost rare disease product development.[ Price : $8.95]
FDA sues dietary supplement maker James G. Cole seeking a permanent injunction against its alleged promotion and distribution of u...[ Price : $8.95]
FDA denies a Watson Labs citizen petition seeking additional bioequivalence requirements for generic applicants seeking approval t...[ Price : $8.95]
FDA denies a Prometheus citizen petition request to undertake notice and comment rulemaking to set standards and processes for sin...[ Price : $8.95]
Adverse event reports associated with blood thinners Pradaxa (dabigatran) and warfarin top the list of drug safety problems report...[ Price : $8.95]
MiMedx Group and FDA reschedule a meeting to discuss a recent Untitled Letter the firm received requiring it to obtain a BLA to la...[ Price : $8.95]
FDA approves an Actelion Pharmaceuticals NDA for Opsumit (macitentan) for treating pulmonary arterial hypertension to delay diseas...[ Price : $8.95]
FDA sends pSivida another complete response letter on a resubmitted NDA for Iluvien (fluocinolone acetonide) for treating chronic ...