[ Price : $8.95]
Medexus Pharmaceuticals says FDA has extended the review of its Medac licensors resubmitted NDA for treosulfan and its use in allo...[ Price : $8.95]
FDA issues SSM St. Clare Health Center a 10-observation Form FDA-483 for GMP deficiencies found during an inspection at an outsour...[ Price : $8.95]
FDA posts a draft guidance entitled Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Developme...[ Price : $8.95]
Federal Register notices: FDA classifies three devices into Class 2 based on de novo classification requests Saladax Biomedicals ...[ Price : $8.95]
FDA releases a CVM draft guidance entitled Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies.[ Price : $8.95]
FDA clears an Apple 510(k) for its Apple Watch to be used as an over-the-counter device for assessing the risk of sleep apnea.[ Price : $8.95]
Boehringer Ingelheim plans an NDA for nerandomilast for treating idiopathic pulmonary fibrosis (IPF) after reporting that its Phas...[ Price : $8.95]
Fresenius Kabi recalls (Class 1) one lot of the Ivenix Large Volume Pump primary administration sets after documenting a manufactu...