The Latest Breaking News from FDA

To move the drugs forward, manufacturers may need to follow the agency’s advice for elevating evidence quality

According to the FDA's guidance document on when to submit a 510(k) for changes to an existing device, manufacturers must submit a new 510(k) if there are significant changes to the device's design, materials, or intended use.

With highly effective drugs and treatment options, chronic disease prevalence, and adoption of technology, the biotech market is thriving. Hence, fundamentally solid biotech stocks Illumina (ILMN), Amgen (AMGN), and Entrada Therapeutics (TRDA) could be ideal with anticipated strong earnings reports. Read more.

Policy playbook developed for potential Trump 2.0 term aims to ban abortion pills, increase surveillance and champion fetal personhood

Colorectal cancer rates in children soared 500% in the past two decades. A simple fix by Congress would put cancer research back in the fast lane.

US launches major vaccination campaign in a bid to prevent healthcare strain and potential mutations of H5N1 virus

An operations manager finds relief from her depression with the help of psilocybin, the primary psychoactive component of “magic mushrooms.” A veteran conquers his post-traumatic stress disorder through therapy using MDMA, a synthetic compound known on the street as “ecstasy” or “molly.” A stay-at-home mom tries LSD, otherwise known as…

FDA-approved Shield blood test offers a convenient and effective screening option for colorectal cancer, improving early detection rates.

For men, FDA-approved medications like Minoxidil, the generic for Rogaine®, offer a safe and effective solution for hair loss.

The European Union (EU) has announced a 32 million euro initiative aimed at enhancing vaccine production in Ghana. The announcement was made during the Ghana-EU Business Forum held in Accra.

FDA warns of lead contamination in ground cinnamon sold at discount stores. Consumers advised to discard affected products to avoid health risks.