FDA grants accelerated approval for a Clovis Oncology NDA for Rubraca (rucaparib) for certain patients with deleterious BRCA-mutated (germline or soma...
Adamis Pharmaceuticals resubmits an NDA for Zimhi (naloxone HCI injection) for treating opioid overdose.
President Trump tells reporters at the White House that he has been taking the controversial malaria drug hydroxychloroquine to prevent coronavirus.
An Oklahoma federal court grants a temporary restraining order against Xephyr LLC, doing business as N-Ergetics, and three company officials that requ...
FDA issues an alert about preliminary data from New York University researchers suggesting potential inaccurate results (false negatives) from Abbotts...
Federal Register notice: FDA sends to OMB an information collection revision for General Administrative Practice and Procedures.
Federal Register notice: FDA makes available a final guidance entitled Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.
Alliance for a Stronger FDA deputy executive director Steven Grossman summarizes five key FDA provisions in a White House-opposed House bill introduce...