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

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

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

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

FDA to release new guidance soon, clarifying its regulatory framework related to vaccines, particularly COVID-19 shots. Read ...

Millions of "long COVID" patients coping with debilitating "brain fog" and chronic fatigue, who are looking for answers to ...

The federal judge’s ruling has nothing to do with the merits of Kobach’s scientifically dubious argument that the vaccine isn’t as safe or effective as Pfizer advertised.

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 ...