FDA issues a guidance with requirements for submitting standardized clinical and non-clinical drug study data in an approved electronic format.
FDA accepts for filing the resubmission of a Fennec Pharmaceuticals NDA for Pedmark.
FDA clears a CoreLink 510(k) for the F3D Corpectomy VBR System, a vertebral body replacement that is intended to surgically replace one or more damage...
FDA extends the comment deadline for a discussion paper on how medical device materials information could be communicated.
FDA says its proposed FY 2022 budget seeks $38 million above the current years enacted level to support CDER and CDRH activities involving the opioid ...
FDA approves Boehringer Ingelheim Pharmaceuticals Pradaxa (dabigatran etexilate) oral pellets to treat certain children aged three months to less than...
Gilead Sciences reports favorable mortality risk reductions for its Veklury (remdesivir) in hospitalized Covid-19 patients.
FDA posts a final guidance on chemistry, manufacturing, and controls changes to an approved BLA.