On the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s ...

Have you ever wondered about what became of COVID vaccine companies after the pandemic settled down? Find out in this article ...

If the FDA deems Pfizer’s and Moderna’s updated vaccines “new” products, it’s extremely unlikely the doses would be ready for ...

The US Department of Health and Human Services said Thursday that it aims to accomplish within four years a scientific feat ...

Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.

The plans amount to an extraordinary flex of Robert F. Kennedy Jr.’s power as health secretary to make decisions ordinarily ...

The Cambridge-based biotech company has been trying to reduce operating expenses as it burns cash on its large pipeline.

Moderna faces revenue declines, regulatory setbacks, and market challenges as COVID-19 vaccine demand wanes. Learn more about ...

On a Thursday conference call with investors, Moderna CFO Jamey Mock outlined a roadmap for the mRNA specialist to lower its ...

The US Department of Health and Human Services said it will require that all new vaccines be tested in placebo-controlled trials before they’re licensed for use, raising urgent questions about the ...

The potential change outlined in a statement would require all new vaccines to undergo placebo testing, sparking concerns ...

There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...