Treatments for dry eye disease, neuroendocrine tumors, chronic spontaneous urticaria, Barth syndrome, and migraine are under review.

One in six patients in phase II oncology clinical trials received a treatment that was eventually approved by the FDA, according to a longitudinal study. In a sample of 400 phase II trials that ...

Earlier this year, the United States Department of Health and Human Services Office of the Inspector General (HHS OIG) ...

Travere Therapeutics (TVTX) has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration seeking priority review ...

The FDA has approved two new biosimilars of denosumab for all indications of the reference medications Prolia and Xgeva, ...

The approvals for Celltrion's denosumab-bmwo (Stoboclo and Osenvelt) mark the third FDA green light for a biosimilar to treat ...

Proportion increases when considering off-label use but drops when considering drugs with substantial clinical benefit.

After more than six years of development, Angle has scored an FDA approval for Parsortix as a ... by harvesting cells from a patient blood sample. In a statement, the UK medical device firm ...

The study found that just 20% of trials submitted to both the FDA and European Medicines Agency had matching evidence.