The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) on Friday released an untitled letter sent earlier this month to Nascent Biotech for improperly promoting pritumumab, an investigational new drug to treat bra...

The US Food and Drug Administration (FDA) on Friday finalized guidance on developing drugs to treat smallpox, clarifying aspects of a revised draft guidance released last year.

As the European Medicines Agency (EMA) announced that it’s finally completing its move from London to Amsterdam, its Committee for Medicinal Products for Human Use (CHMP) on Friday recommended five new medicines for approval, revealed the outcomes...

After failing to file required annual reports related to four new drug applications (NDAs), the US Food and Drug Administration (FDA) on Friday proposed to withdraw approval of the NDAs, although the NDA holders can request hearings.

The European Medicines Agency (EMA) on Thursday issued a guideline setting its expectations for the clinical development of new urate-lowering therapies (ULT) and anti-inflammatory drugs to treat gout.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Thursday voted 16-0 to recommend that the agency expand the label of Amarin’s Vascepa (icosapent ethyl), a derivative of fish oil, to add an indication on reducing the risk of card...