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FDA accepts for review an Acer Therapeutics NDA for Acer-001 sodium phenylbutyrate) for treating patients with urea cycle disorder...[ Price : $8.95]
FDA announces a 10/21-10/22 virtual workshop on fetal pharmacology and therapeutics.[ Price : $8.95]
FDA publishes an International Council on Harmonization addendum expanding testing methods for human carcinogenicity risk studies....[ Price : $8.95]
FDA warns The Medicine Shoppe in Port Charlotte, FL, that it is producing compounded drugs that dont meet legal requirements and d...[ Price : $8.95]
FDA medical reviewers raise issues with two trials of Takedas maribavir to treat cytomegalovirus.[ Price : $8.95]
Takeda Pharmaceutical Co. stops two Phase 2 studies of TAK-994, an investigational oral orexin agonist for treating narcolepsy, a...[ Price : $8.95]
Federal Register notice: FDA makes available a guidance entitled #268 Adaptive and Other Innovative Designs for Effectiveness Stud...[ Price : $8.95]
FDA publishes four final guidances encouraging new sponsors of new animal drugs to pursue innovative ways to prepare and submit da...