After years of back-and-forth with the FDA over Hetlioz's potential use as a jet lag disorder treatment, Vanda Pharmaceuticals is pursuing a new route to establish the drug in the space. Hetlioz was ...
The FDA issued a CRL for ONS-5010, citing the need for additional confirmatory efficacy evidence despite previous trials ...
Developers of a lab-grown blood vessel designed to save life and limb in emergency scenarios appear to be promoting its use in surgeries far beyond what the Food and Drug Administration has approved ...
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