Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for ICOS Corp.'s Zydelig (idelalisib) is 2...
FDA publishes a question-and-answer document to clarify provisions of the harmonized Q11 guidance on development and manufacture of drug substances.
FDA approves a KemPharm NDA for Apadaz (benzhydrocodone, and acetaminophen) for the short-term (no more than 14 days) management of acute pain.
FDA accepts for review a Mallinckrodt NDA for stannsoporfin, indicated for treating neonates at risk for developing severe hyperbilirubinemia, or seve...
FDA accepts for filing a Shire BLA for lanadelumab to treat hereditary angioedema and will give it a priority review.
FDA says a 10-year follow-up study confirms an increased risk of heart problems in heart disease patients prescribed Biaxin.
CNBC reports that FDA commissioner Scott Gottlieb wants changes in right-to-try legislation being backed by President Trump.
PricewaterhouseCoopers says FDA approved 14% more generic drugs in 2017 than in 2016.