BioSpace reviews the 10 biggest drug approvals of 2021, headlined by Biogen’s Aduhelm (aducanumab) as the first drug approved for Alzheimer’s disease in almost 20 years.
Mike Hidock, Director of Quality and Compliance Services at IQVIA, analyzes key considerations for preparing quality management systems (QMS) for fast tracked COVID-19 treatment approvals.
The year 2018 saw a number of significant triumphs in the biopharma industry – increased numbers of drug approvals and near record-shattering IPOs, but the industry also saw its share of blemishes and black eyes from various corners of the globe.
China plans to accept data from overseas clinical trials to speed up approvals of drugs, a potential boon for international drugmakers as well as patients.
In the rush to approve new medicines, the U.S. Food and Drug Administration often requires drug companies to study possible side effects and alternative doses for medicines once they hit the broader market.