FDA clears a Molli Surgical 510(k) for Molli, a wire-free localization technology for marking lesions to be removed during breast cancer surgery.
HHS and FDA withdraw a 1/15 Statement of Policy directing the agency to publish certain information regarding the timeline for its review of drug prod...
FDA approves AstraZenecas Farxiga (dapagliflozin) to reduce the risk of glomerular filtration rate decline, end-stage kidney disease, cardiovascular d...
FDA accepts for review an Intra-Cellular Therapies supplemental NDA for lumateperone, indicated for treating depressive episodes associated with Bipol...
HutchMed completes a rolling NDA submission for surufatinib for treating pancreatic and extra-pancreatic neuroendocrine tumors.
An International Council for Harmonization expert working group announces two meetings (5/18-19) to provide an update on the progress to revise its IC...
Acella Pharmaceuticals recalls certain lots of its NP Thyroid (levothyroxine and liothyronine) 15-mg, 30-mg, 60-mg, 90-mg and 120-mg tablets because r...
Federal Register notice: FDA announces that an information collection entitled Data to Support Drug Product Communications has been approved by OMB....