[ Price : $8.95]
Fujirebio Diagnostics files a 510(k) for the Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test for use in asse...[ Price : $8.95]
FDA posts a transcript from a 10/27 CDRH public meeting on reauthorizing the Medical Device User Fee Act program that outlined age...[ Price : $8.95]
FDA says it is accepting proposals to assess the impact of extended-infusion beta-lactam antibacterial drugs on the development of...[ Price : $8.95]
FDA grants AlloMek Therapeutics an orphan-drug designation for its macrocyclic MEK kinase inhibitor, CIP-137401, for treating neur...[ Price : $8.95]
FDA grants Mesoblast Ltd. a Fast Track designation for remestemcel-L for treating acute respiratory distress syndrome due to Covid...[ Price : $8.95]
The Association for Accessible Medicines asks FDA to clarify several issues from a draft guidance on instances when a generic drug...[ Price : $8.95]
PhRMA uses a citizen petition to ask FDA and HHS to stop moving forward on their proposal to allow some drug importation from Cana...[ Price : $8.95]
Four stakeholder companies raise questions about an FDA draft guidance on using physiologically based pharmacokinetic analyses in ...