The delay follows leadership changes within the FDA. Dr. Scott Steele has been appointed acting director of the agency’s ...

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Kennedy, a well-known vaccine skeptic, last week announced plans to reshape federal public health agencies, including cutting ...

Massive cuts at the FDA have hit staff tied to drug reviews and user fees, putting future approvals in jeopardy, according to ...

The delay dovetails with moves by Republican lawmakers in at least seven states to ban or limit mRNA vaccines. Some, ...

The FDA was supposed to make a final decision about approval of Novavax's COVID-19 vaccine this week, but that deadline has ...

Amid a period of great upheaval at the agency, the FDA has missed its deadline to decide on approval for Novavax’s COVID-19 ...

Novavax started the week hoping the FDA would issue a full approval of its Covid vaccine. But the decision never came.

Novavax's COVID-19 vaccine received FDA Emergency Use Authorization, but full approval faces delays as regulators request more data beyond the April 1 deadline.

The delayed decision comes amid a major organizational shakeup that included the departure of top vaccine official Peter ...

President Trump yesterday announced a baseline tariff of 10% on all imported products and higher rates on certain countries ...

The Food and Drug Administration had already indicated that it approved the vaccine, but new agency leaders are now requesting more data. Meanwhile, FDA staffers who oversaw expert panel meetings on ...