[ Price : $8.95]
AbbVie files an NDA for elagolix, an investigational, orally administered gonadotropin-releasing hormone antagonist, indicated for...[ Price : $8.95]
Stakeholders praise FDA for enforcement discretion for manufacturers to meet Drug Supply Chain Security Act product identifier req...[ Price : $8.95]
FDA warns a Netherlands firm it is marketing a medical device in the U.S. without agency approval or clearance.[ Price : $8.95]
FDA places a clinical hold on two Cellectis Phase 1 studies involving cell therapy UCART123 in acute myeloid leukemia and in blast...[ Price : $8.95]
FDA warns Steiner Biotechnology about violations in its role as a sponsor-investigator of medical device clinical trials.[ Price : $8.95]
FDA warns Entellus Medical about violations in its work as sponsor of a medical device clinical study.[ Price : $8.95]
Six health groups ask FDA to remove ultra-high dosage unit opioid analgesics from the market because their harms outweigh the bene...[ Price : $8.95]
FDA publishes a guidance listing items to consider when developing and designing interoperable medical devices.