The FDA overstepped its authority when it issued a rule last May to bring laboratory-developed tests under the agency’s ...

Vertex lost a legal battle against the federal government on Monday over its proposed fertility support program that would ...

Vaxcyte’s stock price dropped by 50% on Monday after the company reported new Phase 2 data from a study evaluating an ...

FDA biologics chief Peter Marks resigns over vaccine dispute with HHS Secretary RFK Jr., causing biotech stocks to drop.

As­traZeneca has great am­bi­tions for its mid-stage oral cho­les­terol drug, be­liev­ing that it could reach peak sales of ...

Corcept Therapeutics’ oral glucocorticoid receptor antagonist has improved survival outcomes in a late-stage test in patients ...

Phase 2 results on Eli Lilly’s experimental heart disease drug showed it could be dosed far less frequently than competing ...

A New York City drug developer led by well-known executives and backed by some of the top names in biotech investing is ...

LifeMine restructures with layoffs; PTC's Translarna is pulled in Europe; Opthea ends AMD trials; Apollomics and LaunXP make ...

Vertex halts VX-264 diabetes cell therapy due to poor efficacy in Phase 1/2 study, but continues Phase 3 trial of zimislecel ...

A federal judge on Monday dismissed a Johnson & Johnson subsidiary’s third attempt to settle tens of thousands of talc cases ...

BiomX's BX211 virus therapy shows promise in Phase 2 trial, reducing foot ulcer size in diabetic bone infection patients ...