The FDA accepted Novo Nordisk's NDA for an oral formulation of Wegovy. The agency is expected to release its verdict on the ...

The cell and gene therapy space in recent months has hit several speedbumps, including layoffs, dropped drugs and ...

The FDA’s user free programs account for just under half of the agency’s budget—money that could be imperiled by the recent ...

Beam Therapeutics and Verve Therapeutics have each built their lead candidates on a technique billed as a safer alternative ...

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 ...

The new policy, revealed by the Department of Health and Human Services on Wednesday, would make vaccines “less available and ...

No Patient Left Behind says that drug value assessments used in countries like Canada and Germany undervalue innovative ...

Jefferies analysts said Moderna’s first quarter was “in line,” with a miss on revenue offset by a beat on earnings per share.

Like fellow Big Pharmas Eli Lilly and Johnson & Johnson, Amgen is urging the Trump administration to consider tax policy ...

Some 20 travel staff at the FDA, who made arrangements for the regulator’s inspectors, will be getting their jobs back, as ...

Major pharmaceutical companies are committing billions to US manufacturing in an effort to avoid steep tariffs threatened by ...

As the Trump administration—including HHS Secretary Robert F. Kennedy Jr.—plays fast and loose with scientific studies and ...