Janssen files an NDA for esketamine nasal spray, indicated for treatment-resistant depression in adults.
Federal Register notice: FDA announces the charter renewal for two years of its Cardiovascular and Renal Drugs Advisory Committee.
Federal Register notice: FDA renews for two years the charter of the Endocrinologic and Metabolic Drugs Advisory Committee.
Stakeholders express general support for an FDA guidance on shared system REMS and offer suggestions for changes to it.
Helius Medical Technologies seeks de novo clearance of the portable Neuromodulation Stimulator device for treating chronic balance deficit due to mild...
Sanofi settles a Securities and Exchange Commission probe into alleged illegal payments to government officials and healthcare professionals in severa...
FDA releases its latest batch of Warning Letters that includes one medical product company Zimmer Biomet.
Pfizer and Lilly seek changes to an FDA guidance on formal meetings between FDA and sponsors or applicants of Biosimilar User Fee Act products.