The decision had been expected by April 1, but the agency now says it needs more information before moving forward.

Novavax NVAX shares soared 11.4% in the last trading session to close at $6.24. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the ...

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

We recently published a list of 10 Unstoppable Stocks That Could Double Your Money. In this article, we are going to take a ...

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

While it’s not unusual for certain positions to turn over with a new administration, the number of senior-level FDA staffers ...

As the respiratory syncytial virus (RSV) vaccine field grapples with a significantly reduced market size thanks to regulatory ...

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

The FDA has delayed granting full approval of Novavax's COVID-19 vaccine despite it being on track to be cleared until ...

Novo Nordisk is licensing a drug called LX9851 from Lexicon Pharmaceuticals for up to $75 million in upfront and near-term ...

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.