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An AstraZeneca and University of Oxford Phase 3 vaccine study stalls as a clinical hold is issued due to a serious adverse reactio...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Pharmacokinetics in Patients with Impaired Renal Function ...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension for Electronic Submission Process for Voluntary Alle...[ Price : $8.95]
Federal Register notice: FDA announces a 10/8 joint advisory committee meeting to review an Arbor Pharmaceuticals NDA for a drug t...[ Price : $8.95]
Federal Register notice: FDA issues Nippon Shinyaku a priority review voucher after approval of its rare disease drug Viltepso (vi...[ Price : $8.95]
FDA posts a final guidance entitled Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: E...[ Price : $8.95]
FDA accepts an Ascendis Pharma BLA for its TransCon hGH (lonapegsomatropin), an investigational long-acting prodrug of somatropin ...[ Price : $8.95]
FDA grants Project ALS an orphan drug designation for prosetin and its use in treating amyotrophic lateral sclerosis.