FDA Approvals

On July 6, the US Food and Drug Administration modified the COVID-19 antiviral drug Paxlovid's emergency use authorization to permit state-licensed...

The Vaccines and Related Biological Products Advisory Panel of the U.S. Food and Drug Administration gathered on June 30th to evaluate...

To address more recently circulating coronavirus strains, advisors to the U.S. Food and Drug Administration recently suggested altering the design of...

Parents may soon be allowed to line up their children for vaccinations after Pfizer and Moderna's COVID-19 vaccine application for...

The US handed Novavax a $1.6 billion funding 4 months into the pandemic, in July 2020, to speed the biotech's...

Althera Pharmaceuticals, a producer of cardiovascular drugs, is being investigated by the FDA for its cholesterol oral delivery medicine, Roszet....

Despite a high-profile FDA denial, FibroGen and its collaborators have been able to expand into new markets outside of the...

Bluebird bio has persuaded an expert committee that the benefits of its gene therapy possibility, eli-cel, exceed the risks, at...

Even though the company's analysis found it could reduce the likelihood of mild-to-severe disease, the US Food and Drug Administration...

The US Food and Drug Administration (FDA) has granted Novartis expedited approval for its CAR-T cell therapy Kymriah (tisagenlecleucel) to...