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Federal Register Notice: FDA posts a draft guidance on Physiologically Based Pharmacokinetic Analyses Format and Content.[ Price : $8.95]
Federal Register Notice: FDA determines the regulatory review period for Bristol Myers Squibbs lung cancer therapy Opdivo (nivolum...[ Price : $8.95]
FDA releases a draft guidance on Physiologically Based Pharmacokinetic Analyses Format and Content that outlines the recommended ...[ Price : $8.95]
FDA grants Arsanis fast track status for ASN100 for preventing Staphylococcus aureus pneumonia in mechanically ventilated patients...[ Price : $8.95]
FDA commissioner Robert Califf says that approval of stem-cell therapies should be based on scientific evidence.[ Price : $8.95]
FDA says Medtronic has recalled four neurovascular products due to the risk of coating separation and detachment.[ Price : $8.95]
After a 392-26 passage in the House, the 21st Century Cures Act heads to the Senate and could see a vote as early as next week.[ Price : $8.95]
FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), an anti-PD-1 therapy for treating patients ...