Oct 6, 2015

FDA orders duodenoscope makers to study device cleaning procedures

Federal health authorities are ordering manufacturers of specialized medical scopes to study how the reusable devices are cleaned following a series of life-threatening bacterial outbreaks at U.S. hospitals. The Food and Drug Administration said Monday that the three companies must submit plans to study ...

First drug made with 3-D printer, for epilepsy, gets FDA nod

Aug 5, 2015

First drug made with 3-D printer, for epilepsy, gets FDA nod

The U.S. Food and Drug Administration said Tuesday it has approved the first drug made with a 3-D printer — pills for treating epilepsy. The Ohio-based company Aprecia Pharmaceuticals said its system can produce doses of up to 1,000 mg per tablet. It said ...

Mar 16, 2015

Studies boost hopes for new class of cholesterol medicines

New research boosts hope that a highly anticipated, experimental class of cholesterol drugs can greatly lower the risk for heart attacks, death and other heart-related problems. The U.S. government will decide this summer whether to allow two of these drugs on the market. People ...

Feb 4, 2015

Wine-tasting U.S. couple 'left toddlers in freezing car'

A couple allegedly left their two toddlers marooned in a car and strapped into their seats in near-freezing temperatures while attending a wine-tasting event in an upmarket Washington restaurant, U.S. police said. Jennie Chang, 46 — who works for the U.S. Food and Drug ...

Oct 30, 2014

FDA approves vaccine to block meningitis strain

Federal health regulators have approved the first vaccine to block a strain of bacteria that has caused sometimes deadly outbreaks of meningitis in college dormitories. The Food and Drug Administration said Wednesday it cleared Pfizer’s Trumenba to prevent a subtype of meningococcal disease in ...

Oct 14, 2014

Pfizer breast cancer drug to get FDA priority review

Pfizer said Monday an experimental breast cancer treatment will be given an accelerated review by U.S. regulators, speeding up the process for potential approval. The U.S. Food and Drug Administration has granted priority review for palbociclib, which would treat certain postmenopausal women with advanced ...