FDA gives Endologix authorization to begin a pivotal study to evaluate the safety and effectiveness of its Nellix Chimney EndoVascular Aneurysm Sealin...
Federal Register notice: FDA makes available a draft guidance on Fabry Disease drug development.
Evoke Pharma says it will resubmit its NDA for Gimoti nasal spray to FDA by the end of this year.
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.