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Chronic liver disease candidate Ocaliva and the self-administered multiple sclerosis treatment Zinbryta both snagged FDA approval late Friday. Read More
Two compounders are facing FDA warning letters for sterility concerns, with one company being pummeled for numerous other quality deficiencies. Read More
Two foreign API makers have landed FDA warning letters accusing them of violations ranging from data falsification to finished product deficiencies. Read More
France’s National Agency for Medicines and Health Products Safety has ordered French vaccine maker Theravectys to halt production at its Villejuif plant for seven months after apparently finding numerous GMP deficiencies. Read More
A new study of oncology approvals shows that a majority of the candidates approved under accelerated review with surrogate endpoints lacked validation. Read More