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.

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 ...

The dapivirine ring was originally approved in July 2020 to reduce the risk for HIV-1 infection in women 18 years and older ...

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

In a first for the bloc, Europe’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing ...

The European Medicines Agency’s human medicines committee (CHMP) adopted positive opinions for six biosimilar medicines at its June meeting.

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

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

Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its review of semaglutide-containing medicines, confirming a ...

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