[ Price : $8.95]
FDA issues Adamis Pharmaceuticals a second complete response letter on its NDA for Zimhi, a high-dose naloxone injection product f...[ Price : $8.95]
FDA makes available a draft guidance entitled Electromagnetic Compatibility (EMC) of Medical Devices.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance #197 entitled Documenting Electronic Data Files and Statistical Anal...[ Price : $8.95]
FDA sends Sanofi a complete response letter on its BLA for sutimlimab, an investigational monoclonal antibody for treating hemolys...[ Price : $8.95]
Operation Warp Speeds Janet Woodcock says a lesson learned from the Covid-19 experience is the need to establish infectious diseas...[ Price : $8.95]
Huron Therapeutics says it has resubmitted to FDA its NDA for HTX-011, an investigational non-opioid analgesic indicated for treat...[ Price : $8.95]
FDA clears the Lantheus automated bone scan index to be used on the GE Healthcare Xeleris platform.[ Price : $8.95]
Attorney James Beck says a California federal court dismissed two Nexus Pharmaceutical suits against drug compounders due to impli...