The FDA is reviewing the supplemental NDA for cabozantinib in ... absorption and robust efficacy compared with existing DHE products. The Company is seeking approval for acute treatment of migraine ...

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) ...

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

Holdings announced that its supplemental new drug application, sNDA, of Gvoke VialDx has received U.S Food and Drug ...

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

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

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

Doron Therapeutics, a clinical-stage biotechnology company based in Chapel Hill, has received a Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration ...