The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

Incentives to bring vaccines to market are shrinking. Drugmakers are scaling back research investments and cutting jobs.

The U.S. Senate has a plan to improve drug development for rare disease patients. The exit of controversial CBER chief Vinay Prasad will help clear the path.

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

(CNN) — A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that Covid-19 vaccination resulted in the deaths of 10 children. In ...

Montage is still awaiting FDA approval of its Wireless Healthphone, which is meant to send patient data wirelessly to doctors and other caregivers. Healthphone includes blood glucose monitoring ...

The Food and Drug Administration (FDA) on Tuesday granted expanded approval to Wellcovorin for the ultra-rare disease cerebral folate deficiency (CFD) in both children and adults, the same ...

Q4 2025 Management View CEO Jacqueline Shea highlighted that "these are very exciting times for Inovio with our first BLA for INO-3107 as a potential treatment for adults with recurrent respiratory ...

For decades, government intervention into the health care sector has increased at the expense of individual freedom. This disturbing trend is especially prevalent when it comes to the antiquated drug ...