The letter, addressed to Senate Health, Education, Labor and Pensions Committee (HELP) chair Bill Cassidy, R-IL, is written and supported by 207 biotech innovators, including industry heavyweights ...

Treatments for dry eye disease, neuroendocrine tumors, chronic spontaneous urticaria, Barth syndrome, and migraine are under review.

U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low ...

Treatments for COPD, psoriasis, and neuroendocrine tumors, as well as a next-generation COVID-19 vaccine are under review.

The FDA granted a positive review for an acute myeloid leukemia drug trial, with initial dosing expected in 2025.

Fees from food companies could generate much-needed resources to strengthen the FDA’s oversight of foods, say legal and ...

The Food and Drug Administration (FDA) collects user fees from drug and medical device companies to fund its work ensuring ...

The Food and Drug Administration (FDA) collects user fees from drug and medical device companies to fund its work ensuring the safety of these ...

Korean biopharmaceutical firms warn of potential U.S. tariff and FDA approval delays Biotech industry voices anxiety over U.S ...

Massive cuts at the FDA have hit staff tied to drug reviews and user fees, putting future approvals in jeopardy, according to ...