TaiMed Biologics, Inc.

Sponsors of seven new medicines, including three orphan drugs, will know by the end of this week whether the European Medicines Agency’s drug evaluation committee, the CHMP, has recommended their prod

Many of the marketing authorization applications (MAAs) that until recently were being evaluated under the European Medicines Agency’s accelerated assessment mechanism have reverted to standard review

The EU review for Novartis AG / AveXis Inc. ’s novel gene therapy Zolgensma is now going at a more sedate pace after the European Medicines Agency reverted its initial accelerated assessment to a sta

Three orphan drugs including Mitsubishi Tanabe Pharma ’s edaravone for treating amyotrophic lateral sclerosis (ALS) are among the six new medicines that are up for an opinion this week on whether or