Federal Register notice: FDA issues a final guidance on Covid-19: Developing Drugs and Biological Products for Treatment or Prevention.
Teva Pharmaceutical Industries reportedly abandons settlement talks with the U.S. Justice Departments antitrust division over an ongoing generic drug ...
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.