FDA removed the REMS for rosiglitazone-containing Type II diabetes drugs. The move comes 5 years after FDA issued the REMS warning of potential increased cardiovascular risk and 8 years after a meta-analysis first implicated GlaxoSmithKline’s...

Indication Target/marker/pathway Summary Licensing status Publication and contact information Pulmonary disease Emphysema Peroxisome proliferation-activated receptor-g (PPARG; PPARg) Ex vivo and mouse studies suggest agonizing PPARg could help treat emphysema. In lung myeloid dendritic cells from...

EMEA's CHMP recommended that a contraindication be added to the label for rosiglitazone-containing Type II diabetes drugs stating that the thiazolidinedione (TZD) PPAR gamma agonist must not be used in patients with an acute coronary...

FDA and GSK plan to supplement the existing boxed warning on the label of Avandia rosiglitazone to include new language noting that it has been associated with a potential increase in the risk of myocardial...

FDA and GlaxoSmithKline (LSE:GSK; GSK) announced Wednesday an agreement to supplement the existing boxed warning for Avandia rosiglitazone to include new language noting that it has been associated with a potential increase in the risk...

GSK added a boxed warning to the label for Avandamet rosiglitazone/metformin to warn of the risk of congestive heart failure (CHF) and highlight the fact that the diabetes drug is not recommended in patients with...

The companies settled a pair of suits filed in the U.S. District Court for the District of New Jersey, in which GSK alleged that TEVA's generic versions of Avandia rosiglitazone and Avandamet rosiglitazone/metformin infringed GSK's...

FDA said manufacturers of thiazolidinedione diabetes drugs will change the products' labels to include black box warnings against use in patients with heart failure. The warning emphasizes that the drugs may cause or worsen heart...

FDA approved an sNDA for Avandamet as an adjunct to diet and exercise to improve glycemic control in patients with Type II diabetes when treatment with rosiglitazone and metformin therapy is appropriate. The combination of...

GSK issued a "Dear Healthcare Provider" letter for Type II diabetes products containing rosiglitazone - Avandia rosiglitazone, Avandamet rosiglitazone/metformin and Avandaryl rosiglitazone/glimepiride - to warn of new onset and worsening diabetic macular edema, usually accompanied by concurrent...