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) ...
With a U.S. green light for its encapsulated cell therapy technology in the bag, privately held biotech Neurotech ...
Holdings announced that its supplemental new drug application, sNDA, of Gvoke VialDx has received U.S Food and Drug ...
Proportion increases when considering off-label use but drops when considering drugs with substantial clinical benefit.
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.
The FDA is reviewing the supplemental NDA for cabozantinib ... The Company is seeking approval for acute treatment of migraine with or without aura.
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