The Latest Breaking News from US Food and Drug Administration

Washington (AFP) - A panel of experts convened by the US Food and Drug Administration unanimously recommended Covid-19 vaccines Wednesday for children under five, the final age group awaiting immunization in most countries.

Washington (AFP) - After months of waiting for anxious parents, a panel of experts convened by the US Food and Drug Administration recommended Moderna's Covid vaccine Wednesday for the nation's youngest children.

The U.S. Food and Drug Administration (FDA) has granted a Regenerative Medicine Advanced Therapy (RMAT) designation to PolarityTE’s (NASDAQ: PTE)  SkinTE under the its open investigational new drug application (IND).   

The chances of dying following after receiving the Janssen vaccine is about 1:2,000,000. But with multiple COVID-19 vaccines available, the FDA is limiting the use of the J&J vaccine.

The U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to IDEAYA Biosciences (NASDAQ: IDYA) for its drug candidate Darovasertib for the treatment of uveal melanoma.

China is battling with its worst COVID-19 outbreak since 2020. Surging cases of a new omicron variant worldwide are raising concerns that another COVID-19 wave is coming, which could drive demand for future vaccine orders. This bodes well for popular vaccine stocks Pfizer (PFE), Moderna (MRNA), and BioNTech (BNTX), and…

Washington (AFP) - The US Food and Drug Administration (FDA) on Wednesday authorized the first condom for use during anal intercourse, in what was hailed as a victory for sexual health by experts.

A panel of outside advisers to the US Food and Drug Administration on Thursday voted to recommend that Innovent Biologics Inc and Eli Lilly and Co be required to conduct a trial of their lung cancer drug that is applicable to the US population. Data submitted to the FDA for…

Washington (AFP) - The US Food and Drug Administration (FDA) announced Monday that it has granted full approval to Moderna's Covid-19 "Spikevax" vaccine, which had previously received an emergency use authorization in the United States.