Keyword: Food and Drug Administration (FDA)
Amgen and Novartis' migraine drug hit its endpoints in a study of patients who have failed multiple treatments.
The 510(k) nod positions Surmodics to start shipping a device designed for use in the treatment of complex coronary and peripheral lesions.
Surgeons can now use the flexible scope to visualize and access sites in procedures that start with incisions to the abdomen or thoracic cavity.
Drugmakers cannot file regulatory submissions that require the payment of a fee until politicians pass a bill to fund the federal government.
In response to declining venture investment in some disease areas, BIO is releasing reports to identify barriers to innovation.
The FDA has committed to making the U.S. market a top priority for more than 50% of developers of novel devices by the end of 2020.
In a recent report, the Government Accountability Office said the FDA should release plans to issue or revise guidance for complex generic drugs.
Gottlieb talked up the prospect of releasing redacted CRLs in his confirmation hearings but has now watered down his interest in the idea.
The panel felt Aradigm failed to show evidence of the safety and efficacy of Linhaliq in delaying the first exacerbation in chronic lung infections.