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

A top agency official is meeting with industry and FDA staff as he works on guidance clarifying the FDA’s expectations for ...

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

Leaders at the FDA, HHS and elsewhere are putting guardrails around COVID-19 boosters, which could mean delayed shots or ...

The head of the FDA reiterated that the agency is applying a more skeptical approach to this year’s round of COVID-19 vaccine boosters.

As the FDA prepares for a busy Oncologic Drugs Advisory Committee next week, an agency insider told BioSpace that volunteers ...

The judge said a 2022 law that prevented pharmacists from contacting patients about the efficacy of ivermectin and ...

In April 2025, Invivyd secured a $30 million non-dilutive term loan facility with Silicon Valley Bank, a division of First Citizens Bank, supporting balance sheet optionality and providing potential ...

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

Dr. Vinay Prasad, a prominent critic of the pharmaceutical industry and the Food and Drug Administration, has been named to ...

Placebo testing has been part of the process since the 1940s. It’s unclear what additional measures would achieve — but it may slow development.

The FDA has chosen Dr Vinay Prasad, a professor at UCSF, to lead its Center for Biologics Evaluation and Research.