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Federal Register notice: FDA, CDC, and NIH announce an 11/25 public workshop entitled Live Biotherapeutic Products to Prevent Necr...[ Price : $8.95]
Two drug trade associations support an FDA approach to postapproval manufacturing changes in biosimilar and interchangeable biosim...[ Price : $8.95]
FDA approves AstraZenecas Tagrisso for some non-small cell lung cancers.[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for GlaxoSmithKlines Ojjaara (m...[ Price : $8.95]
Two stakeholders say it is important that FDA state that principles in a question-and-answer guidance on pre-approval manufacturin...[ Price : $8.95]
The U.S. House of Representatives passes the Give Kids a Chance Act (HR 3433) that is intended to address childhood cancer and rar...[ Price : $8.95]
FDA releases the form FDA-483 issued following a 2023 inspection at an Eisai drug manufacturing facility in Gifu, Japan.[ Price : $8.95]
FDA accepts for review an Arcutis Biotherapeutics supplemental NDA for Zoryve (roflumilast) foam 0.3% for treating adults and adol...