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Federal Register notice: FDA seeks comments on an information collection extension for the guidance on dear doctor letters.[ Price : $8.95]
FDA approves AbbVies Rinvoq (upadacitinib), a 15 mg, once-daily oral Janus kinase inhibitor and follow-on therapy to its blockbust...[ Price : $8.95]
FDA approves an expanded indication for several transcatheter heart valves to include patients with severe aortic valve stenosis w...[ Price : $8.95]
Federal Register notice: FDA announces a 9/18 panel meeting on a GlaxoSmithKline NDA for the over-the-counter marketing of nicotin...[ Price : $8.95]
Federal Register: FDA makes available a final guidance on osteoporosis drug nonclinical studies.[ Price : $8.95]
A new study shows that FDA and European Medicines Agency reviewers have a high concordance (9198%) in approving/rejecting new drug...[ Price : $8.95]
FDA approves a Harmony Biosciences NDA for Wakix (pitolisant) for treating excessive daytime sleepiness in adult patients with nar...[ Price : $8.95]
The Medical Device Innovation Consortium, of which FDA is a part, says it is soliciting public comments on a white paper on best p...