Feb 3 (Reuters) - AstraZeneca said on Tuesday the U.S. health regulator has rejected its application for a self-injectable ...

Feb 3 (Reuters) - AstraZeneca said on Tuesday that the U.S. health regulator had rejected its application for an ...

Anglo-Swedish drumaker AstraZeneca said on Tuesday that the U.S. Food and Drug Administration has declined to approve its ...

FDA’s new PreCheck pilot streamlines building US pharma manufacturing plants with earlier guidance and faster reviews. Read more here.

Add Yahoo as a preferred source to see more of our stories on Google. One study estimated that in their first year of use, Covid-19 vaccinations averted almost 20 million deaths around the world. - ...

In January, the FDA released its 2026 Priority Deliverables for its Human Foods Program (HFP), which oversees all food safety ...

The FDA launched PreCheck pilot program to strengthen U.S. drug supply chain by improving regulatory predictability.

FDA PreCheck pilot aims to speed U.S. pharma plant construction and approvals for critical medicines with earlier feedback.

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo Dec 3 (Reuters) - The U.S.

Dec 9 (Reuters) - U.S. health regulators informed senior executives at Merck, Sanofi and AstraZeneca last week that their ‌approved protective RSV treatments for infants would face fresh safety ...

In a series of high-impact moves, the FDA is reshaping how it approves and regulates drugs, including accelerating reviews, revising vaccine standards and simplifying biosimilar development.

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans, the latest move by President Donald Trump’s ...