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The Fast Track program of the FDA is designed to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and

"This study underscores the importance of standardizing dosing instructions, which CHPA has long supported as a way of helping parents to appropriately treat their children’s symptoms with over-the-counter

Epilepsy is one of the most common neurological diseases, affecting 70 million worldwide and up to 5 million people in Latin America – and the successful treatment of

The sBLA for Avastin plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) is based on data from the phase III GOG-0240 trial with an FDA action date

Discovered by Otsuka, the new investigational psychotropic compound brexpiprazole is being co-developed with Lundbeck. The NDA for brexpiprazole is supported by seven completed clinical Phase II or III

Albuterol MDPI is also indicated for the prevention of exercise-induced bronchospasm (EIB) in patients 12 years of age and older. Teva senior vice president of Global Respiratory Research

The FDA Office of Drug Evaluation III responded to the Company’s formal appeal filed in response to the Complete Response Letter (CRL) of July 27, 2012 to the

On June 25, 2014, Bioclones and Hemispherx concluded strategic discussions in Johannesburg with three principle goals; 1) initiating studies utilizing Ampligen as a potential adjuvant enhancement of Bioclones’

In the trial, TC-1734 did not meet the objective of showing superiority to donepezil, the marketed medication most often prescribed for Alzheimer’s disease, after 52 weeks of treatment.