A Foley & Lardner client petitions FDA not to approve ANDAs citing Ozempic as the reference-listed drug unless restrictions sought in the petition are...
FDA publishes a CDER Manual of Policies and Procedures outlining the Centers Equal Voice process for ensuring that all staff are heard and valued in p...
HHS revives a task force on safer childhood vaccines, a federal panel created by Congress to improve child vaccine safety, quality, and oversight.
Thoratec recalls (Class 1) its HeartMate Mobile Power Unit AC power cord due to unintended power disconnections.
Texas attorney general Ken Paxton sues Eli Lilly for violating state law by giving illegal kickbacks to healthcare providers as inducements to prescri...
The Justice Department says two men have been charged and one has agreed to plead guilty in a case involving the importation, repackaging, and distrib...
Ocular Therapeutix receives FDA agreement on a Special Protocol Assessment for evaluating Axpaxli in the treatment of non-proliferative diabetic retin...
FDA announces a 12/5 Public Workshop on Pediatric Drug Development Safety and New Approach Methodologies.
