A Food and Drug Administration official who stepped down less than two weeks ago is getting his job back as the agency’s top ...

In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ARCH Venture's latest biotech company, and more.

The FDA action comes weeks after US Health Secretary Robert F. Kennedy Jr said the government would no longer recommend the COVID vaccine for healthy children or pregnant people.

Moderna stock rises on flu vaccine data and FDA approvals, while healthcare stocks remain under pressure amid political uncertainty.

Moderna reported it has received full approval from the U.S. Food and Drug Administration for its COVID-19 vaccine, Spikevax, in children six months through 11 years of age, who are at an ...

Rather than granting approval for all children starting at 6 months of age, the FDA limited its approval of Moderna's pediatric COVID-19 vaccine to children known to have at least one high-risk ...

The company announced the FDA’s full approval in a statement July 10, noting its COVID-19 vaccine, mRNA-1273, was previously available for pediatric populations under emergency use authorization ...

The FDA in 2022 announced a ban on the sale of Juul e-cigarettes nationwide, saying the company did not prove that keeping its products on the market “would be appropriate for the protection of ...

The FDA has rejected Replimune’s request for approval of RP1, adding the melanoma drug candidate to the list of assets to receive complete response letters from the new-look agency.

The FDA’s approval of the natural food dye relates to the ongoing removal of petroleum-based dyes from major food brands, including Kraft Heinz, General Mills, and Nestle, just to name a few.

The manufacturing-related rejection also delays a key test of the new FDA leadership’s support for cell and gene therapy against rare diseases.

The FDA Just Axed 52 Food Standards – Here's What It Means for Your Groceries With fewer standards in place, the information on your food labels might be less reliable than ever.