FDA accepts for review a Pain Therapeutics NDA resubmission for Remoxy ER (oxycodone capsules), indicated for treating severe pain.
FDA extends the PDUFA review target date for Allergans Ulipristal.
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...
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...
FDA approves a Medtronic PMA supplement for a new arm indication for the Guardian Sensor 3 glucose monitor that will enable patients to wear the senso...