[ Price : $8.95]
FDA approves Inspire Medical Systems Inspire V therapy system which includes the next generation neurostimulator for treating slee...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled M12 Drug Interaction Studies and the supplemental document ...[ Price : $8.95]
FDA grants Adaptimmune an accelerated approval for its BLA for Tecelra (afamitresgene autoleucel), a gene therapy indicated for tr...[ Price : $8.95]
FDA grants Cellectis an orphan drug designation for CLLS52 (alemtuzumab), an investigational therapy for treating relapsed/refract...[ Price : $8.95]
FDA clears a DePuy Synthes 510(k) for its VELYS Robotic-Assisted Solution and its use in unicompartmental knee arthroplasty.[ Price : $8.95]
FDA approves an Octapharma supplemental NDA for the expanded approval of Fibryga (fibrinogen) for fibrinogen replacement in bleedi...[ Price : $8.95]
Federal Register notice: FDA seeks comments on a proposed information collection entitled Risk/Safety Considerations and Motivatio...[ Price : $8.95]
CDER posts an updated 2024 guidance agenda listing 101 guidances in 17 categories.