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

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

An Irish woman who headed Ireland’s medicine’s watchdog has been appointed to take over as Executive Director of the European ...

The EMA has given a positive opinion for the exceptional circumstances authorization of Imreplys (sargramostim) to treat myelosuppression after acute radiation exposure.

Despite representing 18% of the global population, Africa accounts for less than 2.5% of global clinical trials. This ...

The European Union's medicine regulator has begun a review of some medicines that contain sodium oxybate and are used to treat alcohol withdrawal syndrome, it said on Friday. Sodium oxybate is an ...

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 ...

GSK has applied to the European Medicines Agency to expand use of its respiratory syncytial virus (RSV) vaccine to adults ...

GSK (LSE:GSK) announced that the European Medicines Agency accepted its regulatory application to expand the use of its RSV ...

A comprehensive analysis conducted by public health experts at Novartis Romania reveals that Romanian patients may wait, on ...

Lorraine Nolan has been appointed to the high-profile role as head of the EU’s drug agency. She was appointed executive director of the European Union Drugs Agency after receiving a two-thirds ...

(RTTNews) - Tempest Therapeutics (TPST) announced that the European Medicines Agency has granted Orphan Drug Designation to amezalpat, an oral, small molecule, selective PPAR antagonist for the ...