Robert F. Kennedy Jr., who oversees the FDA, intends to set new regulatory standards vaccine manufacturers couldn’t possibly ...

"I have tremendous confidence in the many scientists, inspectors, and staff at the FDA to help accomplish these goals and am excited to work with them," said new FDA commissioner Dr Marty Makary.

On the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s ...

HealthDay News — The US Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) announced a new initiative called “Generation Gold Standard” to develop ...

As BioNTech progresses with its goal to grow into a “fully integrated immunotherapy powerhouse,” the German biotech is e | ...

Steven Hatfill promoted hydroxychloroquine during the pandemic. Decades earlier he was wrongly connected with the anthrax ...

A Department of Health and Human Services spokesperson called the move "a radical departure from past practices." ...

The Department of Health and Human Services says it will require new vaccines to be tested against a placebo, which could ...

The FDA has rehired at least some workers tasked with releasing public records generated by the agency’s regulatory ...

Researchers aim to develop a universal vaccine platform that could protect against both COVID-19 and influenza without annual ...

HHS and the National Institutes of Health plan to develop universal vaccines targeting a broad range of flu and coronavirus strains using a new whole-virus platform. The platform, dubbed Generation ...

The FDA is expected to unpause the only protein-based COVID-19 vaccine's transition from emergency approval to full approval.