EMA launches a social media campaign to highlight how the European medicines regulatory network keeps medicines available in Europe safe and effective.
As of today, EMA will start sharing a series of info-cards on its Twitter and LinkedIn accounts.

U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults. These are the first FDA-approved treatments for ATTR-CM. Vyndaqel and Vyndamax have the same active moiety, tafamidis, but they are not substitutable on a milligram to milligram basis and their recommended doses differ.

Pre-exposure prophylaxis (PrEP), a combination drug used to prevent HIV infection, has already gained significant traction in the U.S. and Europe. The once-a-day pill, when taken consistently, can reduce the risk of HIV acquisition by over 85 percent. A new study published in Clinical Infectious Diseases by an international research team suggests that making PrEP available to men who have sex with men (MSM) and people who inject drugs (PWID) in India may be a cost-effective way of curbing the epidemic there.

There has been a growing discussion in recent months around the safety of certain breast implants, with regulatory agencies around the world weighing the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). It’s an issue that has been a priority for us at the U.S. Food and Drug Administration since 2011 when we warned women that the available information at the time indicated that there is a risk for women with breast implants, especially those with textured implants, for developing this disease.