We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Sixteen Democratic and independent senators wrote to HHS Secretary Alex Azar urging him to negotiate lower prices for the opioid overdose reversal drug naloxone. Read More
An FDA advisory committee voted unanimously to recommend approval of a drug for Lennox-Gastaut syndrome and Dravet syndrome that, if approved, would be the first FDA-approved cannabis-derived product, GW Pharma’s NDA for a cannabidiol oral solution. Read More
A California appeals court revived a lawsuit against GlaxoSmithKline in which the plaintiffs claimed the company failed to properly warn non-English speakers about the risks of its antidiabetic drug Avandia (rosiglitazone). Read More
Drug manufacturers found to be fueling the opioid crisis would face marketing limitations and stiff fines under legislation introduced by Sen. Bernie Sanders (I-Vt.). Read More
The Drug Enforcement Administration proposes to limit the production of opioids when setting production quotas by taking into account how often the prescribed drugs are illegally diverted from the individuals for whom they were prescribed. Read More
The EU reassigned oversight of more than 370 centrally authorized drugs from UK agencies to other EU member states in anticipation of Brexit. Read More
CDER’s Office of New Drugs issued a new manual of policies and procedures, effective immediately, concerning NDAs for parenteral drugs that will be packaged in plastic immediate containers. Read More