FDA Approvals

The FDA recorded only 37 new drug approvals in 2022, down from an annual average of 51 since 2017. After...

The generic version of the COVID-19 oral antiviral therapy candidate nirmatrelvir has been approved by the World Health Organization Prequalification...

The first gene therapy for non-muscle invasive bladder cancer (NMIBC) in individuals with high-risk carcinoma in situ (CIS) with or...

The agency that suggests which medications should be allowed in Europe has backed five new ones, including a gene therapy...

What changes are in store for the European Human Medicines Directive and Regulation when it is amended at the end...

There is a new medicine that has surpassed Bluebird Bio as the costliest in the world. Hemgenix, a haemophilia B...

Under new regulations that would oversee a pandemic agreement approved by the World Health Organization, which Reuters has reviewed, pharmaceutical...

According to the new whitepaper Embracing Science with Confidence: Adopting the Revised 2022 WHO Biosimilars Guideline from the International Generic...

Australia is the first country in the world to have awarded regulatory approval for faeces transplants. The healthy genetic material...

The confidential agreement reached by the NHS and the manufacturer is expected to assist up to 1,600 women annually who...