Federal Register notice: FDA makes available a final guidance entitled Development and Submission of Near Infrared Analytical Procedures.
Axsome Therapeutics warns investors of a potential review delay for its NDA for AXS-05 (dextromethorphan bupropion) for treating major depressive diso...
The White House denies that a rumored candidate for FDA commissioner, former Obama White House advisor Ezekiel J. Emanuel, is in the running for the a...
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...