European Medicines Agency (EMA)

The most innovative cancer drugs take longest to reach patients, study suggests

The most innovative new cancer drugs are taking longer to pass through clinical trials, licensing and eventual appraisal by the National Institute for Health and Care Excellence, an analysis carried out by the Institute of Cancer Research has suggested.…

Another manufacturer recalls ranitidine products over NDMA contamination

Medley Pharma has recalled unexpired stocks of ranitidine over possible contamination with N-nitrosodimethylamine.…

EMA committee recommends caution in use of tofacitinib owing to increased risk of blood clots

The European Medicines Agency’s Committee for Medicinal Products for Human Use has endorsed recommendations that tofacitinib could increase the risk of blood clots in the lungs and should be used with caution in all patients already at high risk.…

First non-injectable treatment for severe hypoglycaemia recommended by EMA committee

A European Medicines Agency committee has recommended the first non-injectable treatment for severe hypoglycaemia.…

Medicines recall drug alert issued for potentially contaminated ranitidine products

Pharmacists are being advised to stop supplying some ranitidine products after it was revealed that they may be contaminated with the impurity N-nitrosodimethylamine.…

Safety committee recommends limiting use of high-strength estradiol creams for postmenopausal women

The European Medicines Agency’s safety committee has recommended limiting use of high-strength creams containing 100 microgram/gram of estradiol to a single treatment period of up to four weeks.…

EMA tells drug manufacturers to test for probable carcinogen

The European Medicines Agency has told drug manufacturers to test all medicines that contain chemically synthesised active substances for the presence of nitrosamines.…

First subcutaneous infliximab recommended for approval by EMA committee

The European Medicines Agency’s human medicines committee has recommended approval of the first subcutaneous version of biosimilar infliximab.…

European Commission approves first CBD medicine for severe epilepsy

A cannabidiol-based medicine for severe epilepsy has been given marketing approval by the European Commission.…

EMA to begin review of ranitidine medicines after impurity found

The European Medicines Agency is to start a review of ranitidine medicines after tests revealed that some products contain the impurity N-nitrosodimethylamine Source: European Mediciens Agency Guido Rasi, executive director at the European Medicines Agency, s…