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 ...

The advisory committee meeting is an important step in the process of readying boosters for the fall and winter season, but ...

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 ...

"The record contains troubling evidence that Merck sought to extend its apparent monopoly by misrepresenting facts about its mumps vaccines on the FDA-approved drug labeling." Essentially ...

Analysis found 25% tariff on pharmaceutical imports would hike U.S. drug costs by nearly $51 billion annually, boosting prices as much as 12.9% ...

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 Novavax to ...

"Without trials, it is only a matter of time before the FDA approves a vaccine that causes some bad outcome like vaccine-induced narcolepsy. If this happens, you can kiss faith in vaccines goodbye.

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.

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 ...

In this week’s edition of InnovationRx, we look at a patent fight over the world’s top-selling drug, breakthroughs from the ...