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Astellas Pharma got an FDA green light last week when the agency accepted its New Drug Application (NDA) for fezolinetant — potentially the first-ever nonhormonal drug for hot flashes associated with menopause. Read More
To stretch the available doses, the FDA issued an emergency authorization that allows for a one-fifth dose to be administered beneath the top layer of the skin. Read More
It’s not just academia- and industry-funded trials that are lacking in transparency; a recent audit by the Office of Inspector General (OIG) has found that the National Institutes of Health (NIH) failed to ensure that the results of the trials it funded were posted on ClinicalTrials.gov in line with federal reporting requirements. Read More
A federal court judge in Delaware has ruled in favor of Exela Pharma Sciences on all counts in a patent dispute over Eton Pharmaceuticals’s abbreviated new drug application (ANDA) to produce a generic version of Exela’s product Elcys. Read More
Despite getting a renewed green light from the FDA, Homology Medicines is putting the brakes on its phase 2 trial of a gene therapy for phenylketonuria (PKU) and shifting resources to a potentially more profitable path. Read More
The FDA has accepted Glaxo Smith Kline’s New Drug Application for momelotinib, just months after the behemoth snapped up the investigational myelofibrosis drug and the company that developed it — Sierra Oncology. Read More