Food and Drug Administration Commissioner Marty Makary said his agency may fast-track new drugs from pharmaceutical companies that “equalize” the cost of their medicines between the US and other ...

The idea could help the administration achieve one of President Donald Trump’s main health-care goals: ensuring foreign countries aren’t getting a better deal on drugs.

The Commissioner’s National Priority Vouchers aim to offer accelerated pathways to drugs that meet certain criteria, perhaps ...

For biotech companies advancing oncology therapies, regulatory speed can be critical to achieving key milestones and getting new therapies to patients faster.

The FDA is still on track to meet its user fee targets despite a higher-than-normal vacancy rate among scientific reviewers.

The comments offer insight into an idea floated to help the administration achieve one of President Trump’s main health-care goals: ensuring foreign countries are not getting a better deal on drugs.

The FDA has accepted the New Drug Application for ET-600, an oral solution formulation of desmopressin, for the treatment of central diabetes insipidus.

The panel voted 10-1 to say the available data does not establish the efficacy of the drug, brexpiprazole, in combination ...

The FDA is reevaluating GlaxoSmithKline’s blood cancer drug Blenrep following mixed results from two phase 3 trials and mounting concerns about eye-related side effects and dosing. The agency is ...

The Food and Drug Administration will consider drug affordability when granting companies new vouchers that speed up approvals of some treatments, the agency's Commissioner Marty Makary told CNBC.