The agency narrowed who can get the shot and added new study requirements that could cost the company tens of millions.

The U.S. Food and Drug Administration ((FDA)) on Saturday approved the COVID-19 vaccine developed by Gaithersburg, Maryland-based biotech Novavax (NASDAQ:NVAX). Accordingly, the protein-based shot, ...

Covid shots are facing greater scrutiny from top federal health officials like RFK Jr. and the FDA's Marty Makary.

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

Another Breakthrough Summit West in the books, and what an excellent event! We kicked off the day with former FDA head Robert ...

FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.” ...

Novavax Inc. (NASDAQ:NVAX) reported first-quarter 2025 sales of $667 million, compared to $94 million a year ago, beating the ...

Novavax (NasdaqGS:NVAX) recently reported a significant financial turnaround for Q1 2025, demonstrating substantial revenue growth and net income improvements. The amending of its collaboration ...

Vaccine maker Novavax is seeking to convert the 2022 emergency authorization of its Covid-19 vaccine into full approval. Yet ...

With new testing requirements, it’s not even clear whether new Covid or flu shots can be made available this fall.

An FDA committee will soon make recommendations about this fall’s Covid-19 vaccines while Novavax still awaits full FDA ...

Also Read: Trump-Era FDA Appointees Request New Trials For Novavax COVID Vaccine, Reportedly Delaying Approval Timeline The COVID-19 vaccine maker reported an earnings per share of $2.93 ...