Federal Register notice: FDA makes available a final guidance entitled M12 Drug Interaction Studies and the supplemental document entitled M12 Drug In...
FDA grants Adaptimmune an accelerated approval for its BLA for Tecelra (afamitresgene autoleucel), a gene therapy indicated for treating certain adult...
FDA grants Cellectis an orphan drug designation for CLLS52 (alemtuzumab), an investigational therapy for treating relapsed/refractory B-cell acute lym...
FDA clears a DePuy Synthes 510(k) for its VELYS Robotic-Assisted Solution and its use in unicompartmental knee arthroplasty.
FDA approves an Octapharma supplemental NDA for the expanded approval of Fibryga (fibrinogen) for fibrinogen replacement in bleeding patients with acq...
Federal Register notice: FDA seeks comments on a proposed information collection entitled Risk/Safety Considerations and Motivations for Purchase and ...
CDER posts an updated 2024 guidance agenda listing 101 guidances in 17 categories.
FDA publishes an International Council on Harmonization Question and Answer guidance to clarify its M12 guidance on drug interaction studies.
