Topic: labeling

Bayer is recalling two lots of its top-selling drugs after a labeling mishap led to them being filled with the wrong hemophilia medicines. 

Generic drug makers scored a win at the FDA as the agency changed its mind on giving them responsibility to update their labels.

Pfizer is recalling a children’s Advil product over a packaging issue it says could result in overdoses.

The FDA has issued a CRL for Regeneron's application to extend the dosing schedule for blockbuster Eylea from eight to 12 weeks.

McKesson Packaging Services is recalling blister packs of Xanax and a stomach drug because of labeling problems.

Impax Laboratories has again been tripped up by labeling issues on a drug and is retrieving a lot of a med for treating epilepsy or bipolar disorders in its most recent recall.

Eli Lilly and Boehringer Ingelheim got the verdict they were looking for Tuesday on a Jardiance label addition. But the vote was closer than the pair would have liked.

Every drugmaker wants to find differentiators for their products. And for Ironwood ($IRWD), it was obvious. Is this a constipation drug that improves abdominal symptoms, or is this an abdominal...