[ Price : $8.95]
FDA publishes a guidance explaining how CVM assesses human user safety in applicable animal drug applications.[ Price : $8.95]
FDA tells NDA and ANDA sponsors they must repeat clinical and bioanalytical studies conducted for their applications by Synapse La...[ Price : $8.95]
Six stakeholders express appreciation for and suggest improvements to an FDA draft guidance on using real-world evidence in non-in...[ Price : $8.95]
Federal Register notice: FDA issues a final rule revising its requirements for current good manufacturing practice, postmarketing ...[ Price : $8.95]
FDA places a partial clinical hold on three Zentalis Pharmaceuticals azenosertib studies after two recent deaths due to presumed s...[ Price : $8.95]
FDA grants Elixir Medical a Breakthrough Device Designation for its novel bioadaptive implant DynamX Sirolimus-Eluting Coronary Bi...[ Price : $8.95]
FDA grants Merck accelerated approval for Capvaxive (Pneumococcal 21-valent conjugate vaccine) for preventing invasive disease and...[ Price : $8.95]
FDA clears an Akili 510(k) for EndeavorOTC (AKL-T01) as an over-the-counter treatment for adults with attention-deficit/hyperactiv...