The vaccine advisory committee is scheduled to meet next week to review and make recommendations for this fall’s updated ...

Rapid scientific advances are accelerating the development of medical innovations, from personalized treatments to curative gene therapies and advanced diagnostic tools. But significant policy and ...

By harmonizing their patient engagement frameworks, the FDA and CMS can transform parallel efforts into a unified pathway ...

Makary announced plans for a new rare disease pathway in an April episode of "The Megyn Kelly Show." The proposal follows ...

The US Food and Drug Administration approved updated Covid-19 vaccines but for a more limited group: adults age 65 and older ...

The FDA's groundbreaking decision to waive clinical efficacy studies for a monoclonal antibody biosimilar revolutionizes drug approval, reducing costs and enhancing patient access.

Perhaps the most interesting of the pile of FDA rejection letters was for Lykos Therapeutics’ MDMA therapy. Letters sent to ...

The U.S. Food and Drug Administration is changing its policy on who should get COVID-19 shots, potentially limiting access to new vaccine formulations as they enter the market. New and updated jabs ...

Minnesota pharmacists and healthcare providers have broad latitude to dispense COVID-19 vaccines, regardless of shifting ...