FDA confirms that four more EU countries can conduct GMP inspections at a level equivalent to those conducted by FDA.
Mylan and Revance Therapeutics enter into a collaboration to develop a proposed biosimilar to Botox (onabotulinumtoxinA).
A new FDA safety alert warns health care professionals and patients not to use compounded drug products made by Little Rock, AR-based Cantrell Drug Co...
Two attorneys say FDA is forcing some drug manufacturing outside the U.S. through its interpretation of rules governing API imports.
FDA posts an International Council for Harmonization guidance E18 Genomic Sampling and Management of Genomic Data.
FDA chooses Booz Allen Hamilton for part of a seven-year $300 million blanket purchase agreement to support implementation of an informatics platform ...
FDA releases two draft guidances to help implement drug tracing requirements in the Drug Supply Chain Security Act.
FDA accepts a Shire BLA for calaspargase pegol (Cal-PEG; SHP663), indicated as a component of a multi-agent chemotherapeutic regimen for treating pati...