FDA grants Dynacure an orphan drug designation for DYN101, an investigational antisense medicine for treating centronuclear myopathies.
The Federal Trade Commission says Boston Scientific has agreed to divest two product lines to resolve antitrust concerns about its acquisition of BTG.
CDER director Janet Woodcock urges the National Institutes of Health to take on research into translational science that can help lower the cost of dr...
FDA authorizes a Helix BioPharma IND to begin a Phase 1b/2 study of L-DOS47 and doxorubicin in patients with advanced metastatic pancreatic cancer.
Sarepta says an erroneous adverse event report in a study of a Duchenne muscular dystrophy gene therapy candidate did not interrupt the study.
Federal Register notice: FDA sends to OMB an information collection extension for its guidance on informed consent for in vitro diagnostic device stud...
Federal Register notice: FDA makes available an annual report entitled Report on the Performance of Drug and Biologics Firms in Conducting Postmarketi...
Federal Register notice: FDA revokes an Emergency Use Authorization issued to InBios International for the ZIKV Detect 2.0 IgM Capture ELISA test.