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FDA denies a Metacel petition asking the agency to require flavoring tests for generic forms of the companys Ozobax.[ Price : $8.95]
FDA publishes a draft International Council for Harmonization M15 guidance on model-informed drug development principles.[ Price : $8.95]
FDA grants MeMed a breakthrough device designation for its MeMed Severity test, intended for use in determining risk assessments i...[ Price : $8.95]
Confirmatory data evaluating Eli Lillys pirtobrutinib in adult patients with chronic lymphocytic leukemia or small lymphocytic lym...[ Price : $8.95]
FDA clears Pentax Medical 510(k)s for new endoscope models for colonoscopy and upper GI use.[ Price : $8.95]
Federal Register notice: FDA makes available a guidance entitled Standardized Format for Electronic Submission of NDA and BLA Cont...[ Price : $8.95]
FDA updates a Baxter recall (device correction) of its MiniCap Extended Life PD Transfer Sets used in hemodialysis.[ Price : $8.95]
FDA accepts for review a supplemental NDA for Nucala (mepolizumab) and its use as an add-on maintenance treatment for patients wit...