FDA accepts for review a Mallinckrodt NDA for terlipressin, indicated for treating hepatorenal syndrome type 1.
FDA approves an Immunomedics BLA for Trodelvy (sacituzumab govitecan-hziy) for treating adult patients with triple-negative metastatic breast cancer.
FDA posts a ventilator interactive review template for use by those seeking an emergency use authorization.
Three stakeholders suggest changes to an FDA revised draft guidance on nonclinical safety evaluation of drugs and biologics immunotoxicity potential....
Three stakeholders give general and specific comments on an FDA draft bridging guidance for combination products.
Former FDA commissioner Donald Kennedy (1977-1979) dies due to Covid-19 at the age of 88.
Biogen says it is delaying a BLA for aducanumab, a potential treatment for Alzheimers disease that it is developing in collaboration with Eisai Co.
FDA commissioner Stephen Hahn provides a teleconference briefing to House Energy and Commerce Committee members on the agencys response to the coronav...