FDA identifies recipients of two grants under the CDER Standard Core Clinical Outcome Assessments and their Related Endpoints pilot program.
Pfizer says it will ask FDA by the end of the month to convert its Covid-19 vaccines emergency use authorization to a full BLA approval.
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...