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FDA extends by three months its review of a Mallinckrodt NDA for its investigational compound Xartemis XR (oxycodone hydrochloride...[ Price : $8.95]
FDA grants priority review status to Avedro Inc. for an NDA for riboflavin ophthalmic solution/KXL system, a treatment of keratoco...[ Price : $8.95]
Repros Therapeutics says FDA has granted a face-to-face meeting to discuss pivotal efficacy studies for Androxal, an orally active...[ Price : $8.95]
Cubist Pharmaceuticals reports positive results from its Phase 3 clinical trial of antibiotic ceftolozane/tazobactam in patients w...[ Price : $8.95]
Ventrus Biosciences completes enrollment of a second Phase 3 trial of its diltiazem hydrochloride 2% cream in patients with pain r...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Preclinical Assessment of Investigational Cellular and Gene Therapy Products.[ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or In...[ Price : $8.95]
FDA lifts prescribing and dispensing restrictions on rosiglitazone-containing diabetes drugs based on new data that do not show an...