FDA has scrambled to get on top of the compounding pharmacy sector in the wake of the fungal meningitis outbreak, but last week admitted it still faces a fundamental problem--it is unsure of the scale of the problem.
Merck won the FDA's acceptance of a Biologics License Application for its investigational ragweed pollen allergy tablet to be delivered under the tongue.
Novartis has grabbed one of two new indications it was shooting for with its rare disease drug Ilaris, one step toward turning the drug into a blockbuster.
GlaxoSmithKline and Theravance have won FDA approval for their drug Breo Ellipta for treating chronic obstructive pulmonary disease, the third-biggest killer of Americans, the agency announced. The approval comes with an undesirable boxed warning from the agency that LABA therapies boost risk of asthma-related deaths.
Quest Diagnostics will fork over a $70,000 fine to settle claims in New York State that it pursued illegal hiring practices by automatically rejecting applicants with criminal records.
What to do with unused drugs has been a flash point in the U.S. Some states want drugmakers to set up recycling programs, an expense they don't want to undertake.
CytRx has decided to dump a Phase IIb lung cancer study for the number-two drug program in the pipeline after the monitoring committee concluded that the trial was unlikely to find any improvement in progression-free survival compared to standard treatments.
The problem of drug shortages in the U.S. is generally discussed in the industry terms of products, plant remediation and FDA approvals. But when the human element is interjected, particularly the effects of drug shortages on infants, it takes a more tragic tone.
FDA Commissioner Margaret Hamburg is slated to testify Thursday before the Senate Health, Education, Labor, and Pensions Committee, along with a panel made up mostly of compounding industry officials, as part of the continuing congressional investigation into last year's meningitis outbreak tied to a compounding pharmacy.
Abbott Laboratories has locked down European approval for a new diabetes diagnostic, getting the green light to market a test that can help diagnose and monitor diabetics as well as flag patients at risk for developing the disease.