The FDA has granted Fast Track Designation to Lundbeck's investigational drug, amlenetug, a potential new treatment option targeting Multiple System Atrophy (MSA).

The EMA anticipates that the ability to access scientific advice will foster innovation among medical device manufacturers.

HOUSTON - Moleculin Biotech, Inc. (NASDAQ:MBRX), a late-stage pharmaceutical company currently trading near its 52-week low of $0.66, announced it has received the first European regulatory approval ...

Daewoong Pharmaceutical (Co-CEOs Seongsoo Park and Chang-Jae Lee), a leading healthcare company in Korea, announced the ...

One area that medical device manufacturers often overlook in post-market surveillance (PMS) planning for EU MDR and EU IVDR ...

Valneva’s chikungunya vaccine Ixchiq has been greenlit by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) ...

The proposed guidance aims to provide a framework for the approval of personalised mRNA-based cancer vaccines.

The European Medicines Agency (EMA) announced on Monday that it will be discontinuing its presence on X, opting instead to utilize rival platform Bluesky.

Bristol Myers Squibb today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Breyanzi® (lisocabtagene maraleucel; ...

you are required to have a course-by-course evaluation completed by an approved transcript evaluation agency. Precise, word-for-word English translations of all non-English language documents are ...

Britain's relationship to the European Court of Justice (ECJ) is in the news. But what is the ECJ and what does it do? We answer some of the key questions. What is the European Court of Justice?

AMSTERDAM (Reuters) - The European Medicines Agency (EMA) said on Monday it would no longer ... EMA is a decentralised agency of the EU, responsible for the scientific evaluation, supervision and ...