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16 August 2019
A quick look at biopharma’s top-selling drugs (including forecast sales through 2024) reveals a trio of biologic cancer treatments that have been marketed since 1997 and will likely bring in a cumulative total of more than $300 billion.

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16 August 2019
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.  
16 August 2019
Another year, another record number of generic drug approvals and tentative approvals for the US Food and Drug Administration (FDA).
16 August 2019
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...
15 August 2019
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...
15 August 2019
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.
15 August 2019
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Nordisk, Boehringer Ingelheim and others recently told the US Food and Drug Administration (FDA) to better align its draft guidance on drugs to treat nonalcoholic steatohepatitis (NASH) with compensated cirrhosis ...