Watch this critical discussion on how regulators and biotech companies can bridge the expectation gap during the regulatory ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

FDA introduced a new "Plausible Mechanism Framework." Under this policy, certain gene therapies and RNA-based treatments ...

A top FDA official has proposed broad changes to the review and approval process for vaccines, citing a new internal review linking the deaths of 10 children to COVID-19 vaccines. In an internal memo ...

The strength and credibility of the FDA relies on maintaining a clear line between evidence-based, scientific rigor and political priority setting.

The FDA has approved a new higher-dose version of Wegovy, a weight-loss drug, enhancing treatment options for obesity with ...