The missed PDUFA adds to a string of delays at the FDA in recent weeks, including at least two other missed target action ...

A new vaccine developed by Moderna aims to protect against both flu and COVID-19 with just one shot. Early studies suggest ...

A new vaccine that combines flu and COVID-19 protection in one shot shows promising results, but the U.S. Food and Drug ...

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

In the wake of mass restructuring efforts across the Department of Health and Human Services (HHS), the FDA has missed yet another approval decision target date. | GSK had expected to secure an FDA ...

Novavax posts $667 million in Q1 2025 revenue and $2.93 EPS, boosted by Sanofi payments and APA terminations; full-year ...

Q1 2025 Management View CEO John Jacobs highlighted the shift in Novavax's corporate strategy over the past year, ...

Q1 2025 Earnings Conference Call May 8, 2025 8:30 AM ETCompany ParticipantsLuis Sanay - Vice President, Investor ...

After more than a month of speculation over how the FDA will rule on Novavax’s application for an updated formulation of its ...

Moderna also hopes that combining the shots will help improve vaccine rates. Poland, however, is not sure people will like ...

Shares of Novavax, Inc. (NVAX) traded 16% higher on Thursday morning after the company reported upbeat first-quarter (Q1) ...

Senior leaders at the FDA began pushing Moderna and Pfizer to file for full, formal approval of their COVID vaccines for ...