Danish police are investigating the drugmaker over its decision to wait two days before announcing the FDA's February rejection.
The government division is scrutinizing marketing information for three drugs.
Reports of a Dec. 5 deal between the US and China could deepen inspectors' reach.
The leukemia drug is staying on the market, but for a more restricted patient population.
Critics worry the talked-about approval plan could mean adverse events surface far too late.
The agency's bad-ad warning letter calls the new violations "particularly troubling."
The drugmaker's green light was paired with the EMA's decision that several thousand unreported AEs were no big deal.
EyeonFDA finds that, when it comes to black-boxed drugs' marketing materials, the FDA is more likely to issue Warning Letters than untitled letters.
The regulator says the drugmaker needs to do more testing.
The drugmaker's latest financial plans could power it through mid-2015.
The company announced the layoffs Friday.
The proposed change would allow generics makers to update labels even if branded drugmakers do not, possibly opening up generics to new liability issues.
The FDA's Bad Ad group says the drugmaker misbranded its cholesterol drug during interviews on CNBC.
The drugmaker blasted the price-control agency for being shortsighted and underestimating the industry's role in health and savings.
User fees keep the regulator's review process running for some drugs, while others see review dates slip.
Approvals and reviews continue—for now—despite government shutdown.
1,100 workers will lose their jobs at a plant with a history of around 40 recalls.
The CEO says Sanofi's patent-loss turnaround is coming.
The second-line drug sped from Priority Review status for the first-line indication to approval in just over two months.
The regulator says serial filers and time restraints are draining resources and staff.
The agency issued final guidance on mobile apps, saying it will focus only on a subset that present the greatest risk to patients if they don't work correctly.
AbbVie and Galapagos go after cystic fibrosis; FDA's NME approval pace slows; government shutdown could slow ad-com votes; and a report shows privately insured patients had emptier pockets in 2012 than 2011
Complete Response letter slows Merck's suggamedex; AbbVie looks for next Humira; Roche drug gets breakthrough label; FDA effort to better track medical devices
Gilead's Striblid faces hurdle in Germany, Boehringer and Roche team up for companion diagnostic effort and Wisconsin hospital system says no to samples
Australia's price watchdogs are assessing the value of BMS cancer drug Yervoy; why a Phase II weight drug from Zafgen could open up the category; GSK halts a Crohn's trial; and Shire extends Santaris rare-disease collaboration
Eisai uses a lawsuit to prompt the DEA, AHRQ gets a new director, mWellness runs into adherence issues.
Quintiles buys a CRO; Forest and Almirall delay their COPD combo drug; and Paula Deen may pop up on the Food Network Sunday
Eisai lobbies to push back Belviq's patent clock; a case against Paula Deen is dismissed; Merck and Avanir team up to promote Januvia; and another healthcare-reform measure is pushed back
The GSK-Pfizer-Shionogi daily HIV medication gets the regulatory all-clear. The approval could put BMS/Gilead's best-selling daily med Atripla on the defensive.
FDA's Office of Prescription Drug Promotion issued an Untitled Letter over what it says are misleading copy and overstated efficacy claims online.