Two drug trade associations support an FDA approach to postapproval manufacturing changes in biosimilar and interchangeable biosimilar products.
FDA approves AstraZenecas Tagrisso for some non-small cell lung cancers.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for GlaxoSmithKlines Ojjaara (momelotinib).
Two stakeholders say it is important that FDA state that principles in a question-and-answer guidance on pre-approval manufacturing changes to biosimi...
The U.S. House of Representatives passes the Give Kids a Chance Act (HR 3433) that is intended to address childhood cancer and rare diseases.
FDA releases the form FDA-483 issued following a 2023 inspection at an Eisai drug manufacturing facility in Gifu, Japan.
FDA accepts for review an Arcutis Biotherapeutics supplemental NDA for Zoryve (roflumilast) foam 0.3% for treating adults and adolescents ages 12 and ...
FDA releases the form FDA-483 with five observations from a 2023 inspection at the Hugel drug substance and product manufacturing facility in the Repu...
