Covis Pharma B.V.

For the third time, the US Federal Trade Commission has sent warning letters to drug companies, disputing improperly listed patents in the US Food and Drug Administration’s Orange Book. The agency tar

For the third time, the Federal Trade Commission has sent out warning letters to drug companies, disputing improperly listed patents in the US Food and Drug Administration’s Orange Book. In this round

The role of the US Food and Drug Administration’s accelerated approval council in the approval and withdrawal of products is drawing attention as 2025 begins. A new Health and Human Services’ Office o

The US Food and Drug Administration intends to convene an advisory committee when its drug or biologic centers are considering withdrawal of an accelerated approval product. A new draft guidance on