The company said it used "inappropriate expressions" in promotions of a blood pressure medication.
Roche said an onartuzumab and Tarceva mix did not help advanced non-small cell lung cancer patients with MET-positive tumors.
The FDA rejected J&J's expanded indication request a third time.
The Cleveland Clinic finds that 75% of Americans don't worry about dying of heart disease, even though it's the country's leading killer.
A sealed complaint, reported on by the Wall Street Journal, builds on concerns that were already surrounding the now-controversial Plato study.
Positive results from a Phase-III trial edge Amgen's evolocumab closer to approval, though it's still behind rivals in the PCSK9 race.
The FDA panel voted 10-1 for the drug. The assessment included patient weight and health recommendations.
An FDA committee is poised to review a new Primatene Mist in February.
The warfarin replacement will be evaluated in a post-trial safety study, regulators said last Friday.
The American College of Cardiology is contributing its Pinnacle registry to identify clinical trial patients.
The fine is for Pradaxa documents that have gone missing. The company is accused of hiding risk information about its blood thinner.
A poll indicates new cholesterol guidelines won't shake up the statin market in 2014.
The drugmaker revealed the data a year after stopping a Phase III trial.
Phase III clinical trial results underwhelm investors who feel on-market drugs offer better patient value.
The company is rolling out two new clinical trials, and Phase I data suggests an antidote could be on its way.
The calculator meant to help doctors use the new cholesterol guidelines appears to be flawed.
Aggressive new recommendations for treating patients at high risk of cardiovascular disease could significantly alter the treatment landscape.
The drugmaker's latest financial plans could power it through mid-2015.
An investigational cardiovascular heart drug failed to reduce the risk of heart attack or stroke, a miss which some on Wall Street say raises questions about the drugmaker's ability to deliver in late-stage trials.
The FDA told the drugmaker in a letter before the December PDUFA date that evidence does not support an expanded indication.
An advisory committee voted 9 to 2 against expanding the drug's indication.
Three former workers are accused of giving proprietary data to a drug company abroad.
The drug maker says it is accelerating development of new drugs and focusing on expanding indications of current ones.
The $25 million-plus deal is for worldwide rights to an experimental treatment being developed by private firm Gliknik.
The company has off-loaded two medications and a manufacturing site, part of an ongoing effort.
The scandal over Diovan draws regulatory attention.
Sanofi's PCSK9 agent receives high praise from analysts, Consumer Reports analyzes healthcare reform, Congressional committees propose compounding legislation, NIH funds genomic research.
The advisory panel endorsed the treatment with an 11-2 vote.
FDA draft guidance for generic Advair hits GSK's stock; US looks into GSK's China conduct; Roche invests in cancer and hep. B research; Biogen inks a Parkinson's partnership; Forest names former B&L chief as CEO
The experimental LAMA/LABA combination could shake up the category.