Treatments for dry eye disease, neuroendocrine tumors, chronic spontaneous urticaria, Barth syndrome, and migraine are under review.
Holdings announced that its supplemental new drug application, sNDA, of Gvoke VialDx has received U.S Food and Drug ...
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 ...
The approval is only for the 2.5mg tablet. The Food and Drug Administration (FDA) has approved the first generics of Xarelto ® (rivaroxaban) 2.5mg. Xarelto 2.5mg is used, in combination with ...
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 ...
Travere Therapeutics (TVTX) has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration seeking priority review ...
Proportion increases when considering off-label use but drops when considering drugs with substantial clinical benefit.
The study found that just 20% of trials submitted to both the FDA and European Medicines Agency had matching evidence.
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