FDA approves an expanded indication for AbbVies Qulipta to prevent chronic migraines.
The U.S. Supreme Court extends by two days (until 4/21) its administrative stay of a lower courts 4/7 order that would restrict the distribution of th...
An ongoing European Medicines Agency and FDA joint initiative on information sharing involving generic drug bioequivalence study inspections adds Irel...
FDA grants traditional approval of Genentechs Polivy (polatuzumab vedotin-piiq) for combination use with four other drugs in for treating certain adul...
FDA says some elderly and immunocompromised people are now eligible for a second Moderna or Pfizer BioN/Tech Covid vaccine booster as part of a new si...
FDA researchers describe two lessons learned from rare disease clinical trials during the Covid-19 pandemic and their applicability to future trials.
CDER Office of New Drugs Research Program associate director Laura Jaeger describes the regulatory science research the program has funded.
FDA issues Azure Biotech an emergency use authorization for the Azure Fastep Covid-19 Antigen Pen Home Test.
