FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation host a two-day workshop entitled Advancing the Developmen...
Acer Therapeutics and Relief Therapeutics submit an NDA for ACER-001 (sodium phenylbutyrate) for treating urea cycle disorders.
Attorneys from Dechert pick apart FDAs recent intended use rule, which clarifies that the agency will not make a determination of a firms intent regar...
FDA issues a final guidance entitled Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clini...
FDA grants Qiagen an emergency use authorization for its QIAreach SARS CoV-2 antigen test, a rapid portable test that can process an average of around...
FDA has approved a Genzyme BLA for Nexviazyme for intravenous infusion to treat patients one year of age and older with late-onset Pompe disease.
FDA classifies as Class 1 a Boston Scientific recall of its Ingenio pacemakers and CRT-Ps due to safety mode transition error.
FDA releases a final guidance on Development and Submission of Near Infrared Analytical Procedures.