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 ...

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

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

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

The biotech is slashing a third of its workforce and more than half of its executive team in moves it called “necessary in ...

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