ABSTRACT: The assessment of extractable and leachables (E&L) has become a cornerstone of pharmaceutical product safety, yet no unified global standards currently exist to quantify or report E&L from ...

The US Food and Drug Administration on Monday approved Hikma Pharmaceuticals’ generic version of Novo Nordisk’s diabetes drug, Victoza, clearing the way for the launch of another copy of the ...

of N.Y. LLC’s action alleging that Teva Branded Pharm. Prods. R&D Inc. improperly listed inhaler patents in the Orange Book and delayed the entry of generic products onto the market. The appeals court ...

The U.S. Federal Trade Commission, which has warned pharmaceutical companies against submitting irrelevant patents to the FDA to limit generic competition, supported Amneal's lawsuit. A Teva ...

A device costing just pennies, based on an idea by a University of Manchester Professor to help his son use an inhaler, could be a gamechanger for asthma patients. The impressive results are from ...

The drug bazaar that powered this part of southern Afghanistan has been all but emptied. And the nation, already reeling without international aid, has lost a sizable piece of its economy as a result.

The US Food and Drug Administration has placed its most serious warning – a so-called black-box warning – on a drug used to relieve menopausal hot flashes. The FDA says women who are taking ...

The news followed an investigation by POLITICO’s E&E News into climate-friendly inhalers and how drug giants are developing them to undermine competition. The pharmaceutical giant AstraZeneca ...

In some ways, Captagon is the great unifier of the drug world. The synthetic stimulant is used across the Middle East by everyone from truckies and taxi drivers battling through shift work ...