The FDA has approved a new pneumococcal vaccine from Merck & Co, just over a month after Pfizer got a green light for a new version of its market leading Prevnar shot. Merck's Vaxneuvance ...

On the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s ...

Kennedy won Senate confirmation to his job, in part, by promising not to change the nation’s vaccine schedule. Since taking office, he’s promised to “investigate” children’s shots, canceled meetings ...

Analysis found 25% tariff on pharmaceutical imports would hike U.S. drug costs by nearly $51 billion annually, boosting ...

Novavax on Thursday tried to calm investors spooked by the delay of full approval of its COVID vaccine shot by U.S.

The terms need to be negotiated before Novavax’s vaccine could be granted full approval, the source said, declining to be named because they weren’t authorized to speak on behalf of the FDA.

Novavax's COVID-19 vaccine could soon receive full approval from the U.S. Food and Drug Administration (FDA), the company said Wednesday. The update sent Novavax's stock up more than 21% in early ...

The U.S. Food and Drug Administration (FDA) is planning to require all new vaccines to undergo placebo-controlled trials before approval, multiple news outlets reported late Wednesday, citing the ...

It is still being sold under emergency use authorization — unlike mRNA vaccines made by Pfizer and Moderna that have earned full FDA approval for certain age groups. The FDA recently asked ...

In a release issued Monday, Novavax said it responded to an earlier FDA request to commit to providing more data on the vaccine if approved — a standard practice. Dr. Paul Offit, the director of ...