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Coldstream hosted FDA authorities from 8 April – 17 April 2014, at its manufacturing facility in Lexington. The site audit reviewed quality systems to ensure compliance with current

Presence of glass particles has been reported through customer complaint. Administration of glass particulate, if present in an intravenous drug, poses a potential safety risk to patients. Case

The Phase I study is a single-center, double-blind trial designed to evaluate the safety and tolerability of AG-348 through dose escalation in healthy adult men and women. The

According to Akorn, this acquisition will boost the company to transform into a larger, more diversified generic player. The acquisition will also bring critical mass and scale to

GOG-3003 (NCT01666444) is one of the two Phase II clinical trials of VTX-2337 currently in progress. The Phase II GOG-3003 study is being conducted in collaboration with the

According to GSK, this is the first marketing approval granted for Incruse Ellipta anywhere in the world. Incruse Ellipta is GSK’s first long-acting muscarinic antagonist (LAMA) monotherapy, a

The average age of an AML patient is 65-70 years and the currently recommended standard of care is intensive chemotherapy, but many patients due to age and co-morbidities

The drug is indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. As part of a settlement agreement, Genzyme agreed to grant

The two Phase IIb clinical studies were double-blind, pioglitazone-controlled, dose-ranging studies designed to assess the safety, efficacy and tolerability of multiple remogliflozin etabonate doses for 12-weeks in treatment-naïve