The nonprofit Medical Device Innovation Consortium (MDIC) is seeking comments on the first of three resources to support its Framework for Patient Input in Medical Device Clinical Trials, which is set to be complete next year.  

Another year, another record number of generic drug approvals and tentative approvals for the US Food and Drug Administration (FDA).

The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) concur more than 90% of the time in their decisions to approve new drugs, according to a new study from EMA and FDA officials that looked at 107 applications from 2014 t...

The US Food and Drug Administration (FDA) on Thursday granted accelerated approval to Roche’s Rozlytrek (entrectinib), a treatment for adult and adolescent patients whose cancers have the specific genetic defect neurotrophic tyrosine receptor kina...

The US Food and Drug Administration (FDA) on Wednesday released quarterly data on two of its programs aimed at increasing generic competition and speeding the approval of priority generic drugs.

Novartis, Gilead, Regeneron, Novo Nordisk, Boehringer Ingelheim and others recently told the US Food and Drug Administration (FDA) to better align its draft guidance on drugs to treat nonalcoholic steatohepatitis (NASH) with compensated cirrhosis ...