FDA Approvals

The Regenerative Medicine Advanced Therapies designation of RP-A501, which happens to be an adeno-associated virus-based gene therapy when it comes...

The US and Switzerland have agreed to a Mutual Recognition Agreement (MRA) on pharmaceutical Good Manufacturing Practices (GMP). The US...

The biotechnology sector had a decline in 2022 that went beyond just falling stock prices. Additionally, only 37 new drugs...

Atezolizumab (Tecentriq), a therapy for advanced alveolar soft tissue sarcoma (ASPS), has received FDA approval for the first time for...

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...