Rapid scientific advances are accelerating the development of medical innovations, from personalized treatments to curative ...

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

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

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

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

Accelerated Approval (AA) pathway, initially established in 1992 during the HIV/AIDS epidemic to provide faster access to ...

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

Shortly before he was forced to resign, the nation's top vaccine regulator says he refused to grant HHS Secretary Robert F. Kennedy Jr.'s team unrestricted access to a tightly held vaccine safety ...

At the end of August, the Food and Drug Administration approved updated vaccines for COVID-19. While previous versions of the ...

BALA CYNWYD, Pa., June 23, 2025 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare ...