Marks’ resignation leaves the field without a regulator many view as “integral” to its progress over the last decade.

The drug discovery company, which has partnerships with Eli Lilly and Novartis, is developing AI models to design drugs and ...

Shares in Moderna, Vaxcyte, Novavax and BioNTech all fell Monday after Peter Marks, head of the FDA office that reviews ...

Drugs from Novartis, Amgen and now Lilly have proven powerfully effective at reducing Lp(a). Whether that will translate to a ...

In his resignation letter, Marks cited disagreement with HHS Secretary Robert F. Kennedy Jr., who he said pushed ...

Many HHS department heads and staff were unaware of plans to fire some 10,000 employees until they were publicly disclosed ...

The FDA will lose about 3,500 employees under the plans, although HHS said drug, medical device and food reviewers will not ...

A licensing deal with Jiangsu Hengrui Pharmaceuticals puts Merck in a competitive race to develop a medicine that targets a ...

The startup is bringing into Phase 1 testing an experimental treatment it says could be more effective than marketed ...

The new bid surpasses an offer SK Capital and Carlyle Group made last month for the gene therapy developer, which Bluebird’s ...

The Sanofi drug, known as fitusiran and now Qfitlia, was approved on Friday for a broad group of people with the rare ...

Key regulators are not recommending Lilly’s Kisunla be cleared for the European market. The company says it plans to appeal ...