FDA warns Houston, TX-based Empower Pharma about multiple violations in its production of unapproved and misbranded compounded drugs.
The DC federal court throws out Norwichs suit seeking to force FDA to find that Actavis has forfeited its exclusivity for a generic form of rifaximin ...
FDA commissioner Martin Makary says there are no current plans to restrict access to the abortion drug mifepristone.
Abbott recalls its HeartMate Mobile Power Unit to remove the component due to instances where the device experiences a sudden power loss.
Novavax says its Covid-19 vaccine BLA is being held up while FDA seeks to conclude a post-marketing commitment from the company.
FDA grants CereVasc a breakthrough device designation for its investigational eShunt System and its use in treating communicating hydrocephalus.
FDA says its Electronic Submission Gateway Next Generation is live and ready to receive submissions.
Vanda Pharmaceuticals criticizes FDA for wrongly claiming that recent staff cuts and a new commissioner causes it to delay a company request for a hea...
