The head of the Food and Drug Administration said the agency will soon unveil a new framework detailing what companies must ...

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

The GOP-led House Judiciary Committee is requesting records from Pfizer’s CEO and an interview with a former company ...

New requirements for clinical testing of vaccines, announced this month, may delay the availability of shots that had ...

HHS Secretary Robert F. Kennedy Jr. plans to remove CDC recommendations for COVID-19 vaccination in pregnant women and ...

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

The U.S. Food and Drug Administration said on Wednesday it will hold a meeting of experts on May 22 to discuss COVID-19 ...

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

Dr. Vinay Prasad was an outspoken critic of the FDA’s response to the pandemic, including the former vaccine chief, Dr. Peter ...

The advisory committee meeting is an important step in the process of readying boosters for the fall and winter season, but ...

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

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