The new guidance offers a validation template that can assist test developers in submitting an Emergency Use Authorization (EUA) request. 

The Federal Food and Drug Administration (FDA) has amended its emergency use authorizations (EUAs) to include updated booster shots targeting the BA.4 and BA.5 COVID-19 subvariants.

The funding, which is through the Centers for Medicare and Medicaid Services (CMS), includes $98.9 million that will help ensure consumers can navigate health insurance enrollment through the Marketplace, Medicaid and the Children’s Health Insurance Program (CHIP).

The Biden administration has mandated that all federally-funded research become available to the public––for free.

The suit alleges the company’s 401(k) retirement plan invested in low-performing target-date funds in favor of its business relationship with Wells Fargo.

The FDA has had a busy month, overseeing the recall of nearly 88,000 implantable cardiac devices, juggling the continued rise of monkeypox cases in the United States and maintaining an active Breakthrough Devices program. This rundown covers some of the agency's biggest moves during that time. 

Three major pharmacy names will have to fork over hundreds of millions of dollars to two Ohio counties for their roles in the opioid epidemic, a judge has ruled.

The act is Biden’s third major piece of legislation to sign into law since the start of his term, and it accomplishes a healthcare task the Democrats have been wanting for years: enabling Medicare to negotiate prescription drug prices.