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

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

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

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 ...

Pluvicto can now be used before chemotherapy to treat a kind of metastatic prostate cancer, tripling the number of patients ...

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

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

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

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

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

Clearance of Vykat unlocks what analysts anticipate will be a lucrative market opportunity for Soleno Therapeutics.