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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

Upcoming cell and gene therapy guidance could adjust the challenging requirement for up to 15 years of postmarket follow-up and potentially further streamline product development. The US Food and Drug

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 A new draft guidance on

The US Food and Drug Administration is once again warning about an increased risk of serious liver injury with Intercept ’s primary biliary cholangitis treatment Ocaliva (obeticholic acid) in a safet