The advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines.

In an opinion issued late Thursday night, U.S. District Judge Susan Illston wrote that the president and department agency ...

The approval tees GSK up to challenge Sanofi and Regeneron, which in September 2024 won the first biologic approval for COPD ...

The "One Big Beautiful Bill Act" includes negotiation exemptions for orphan drugs approved to treat more than one rare ...

The report takes from HHS Secretary Robert F. Kennedy Jr’s playbook, calling out rising autism rates, the vaccine schedule ...

The CMS last month declined to include anti-obesity medications in its Medicare coverage for Part D, a move that Lilly says ...

Analysts were effusive about Merus’ new HNSCC data, writing that petosemtamab could “become the standard of care” in the ...

Kicking off this week in Chicago, this year’s American Association for Cancer Research conference will feature presentations ...

Canada’s health agency says it has been “taking all necessary action safeguard the drug supply and ensure Canadians have ...

After discussions with the FDA, Moderna has withdrawn its application for a combination shot, which had demonstrated efficacy ...

Nine states in the Southeast showed growth in bioscience employment and establishments from 2019 to 2023, according to 2024 ...

The FDA had given Pfizer and Moderna until May 17 to propose changes to the labels of their COVID-19 vaccines or challenge ...