The European agency has started a review of sodium oxybate to assess its use to treat alcohol withdrawal syndrome and support ...

The European Union's drug regulator on Friday recommended conditional authorisation of Madrigal Pharmaceuticals' Rezdiffra, ...

The European Medicines Agency has begun a review of medicines to treat alcohol dependency that contain sodium oxybate, it said on Friday, following concerns of potential misuse or abuse. The regulator ...

Revenue for Madrigal’s Rezdiffra, already approved in the US, is expected to skyrocket over the coming decade.

The EMA has extended the indications for Darzalex (daratumumab) to the treatment of adults at high risk of developing ...

The latest update atopic dermatitis guidelines include the new approval of lebrikizumab and the expanded use of baricitinib ...

The European Medicines Agency has revealed a list of five cities that are preferred as its new location by staff after Brexit, following warnings of a public health disaster if EU leaders pick the ...

Advert Previous studies linked the drug to a rare eye condition known as non-arteritic anterior ischemic optic neuropathy ...

In looking across the past four years of regulatory decisions, we noticed that some of the analyses involving the European Medicines Agency (EMA)'s cycle time used an inappropriate endpoint ...

European Medicines Agency’s (EMA) human medicines committee (CHMP) has started a review of medicines containing ipidacrine. These medicines have been authorised in several EU countries through ...

The multiple regulatory designations were granted following strong positive results from a global randomized Phase 1b/2 study in first-line HCC demonstrating superior outcomes for amezalpat ...