The Latest Breaking News from FDA

Ford is recalling 500,000 US-market Ford Edge (2015–2018) and Lincoln MKX (2016–2018) SUVs over rear brake-hose leaks that can lengthen stopping distances; owner letters start 8 September 2025 with a fix due from April 2026.

The U.S. Food and Drug Administration (FDA) stated on Thursday that it is requiring an additional MRI scan for Alzheimer's patients receiving Leqembi (lecanemab), citing safety concerns over a rare but potentially fatal side effect.

When a food product is recalled, a rapid response is critical to protect public health. While federal agencies like the FDA and USDA issue national alerts, it is the job of state and local health departments to ensure the dangerous product is actually removed from store shelves. In Alabama, this…

Sen. Elizabeth Warren (D-Mass.) is sounding the alarm on President Donald Trump’s attempts at overhauling leadership at the Centers for Disease Control and Prevention, warning of risks to public health.

Formaldehyde-free hair-straightening products have been marketed as a safer option, but they may pose a risk to kidney health, a case series suggests.

As the demand for affordable healthcare options grows, the pharmaceutical industry is increasingly focused on developing generic drugs to expand access and reduce costs. This trend is driving major players to seek FDA approvals for generic versions of popular medications, reshaping the competitive landscape and providing more choices for consumers.

Operations at the U.S. Centers for Disease Control and Prevention are in jeopardy after the ousting of the CDC director and the resignation of several high-profile agency leaders

Prothena Corporation plc (NASDAQ:PRTA) shared results on Wednesday from the Phase 1 ASCENT clinical program in participants with early symptomatic Alzheimer’s disease (AD).

On Thursday, Telix Pharmaceuticals Limited (NASDAQ:TLX) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for TLX250-CDx (Zircaix, 89Zr-DFO girentuximab), an investigational PET2 agent for the diagnosis and characterization of renal masses as clear cell renal cell carcinoma (ccRCC).

We want to hear people’s views about the change making only those 65 and up automatically eligible for the vaccines

The U.S. Food and Drug Administration (FDA) on Wednesday approved updated Risk Evaluation and Mitigation Strategy (REMS) labeling for Travere Therapeutics, Inc.’s (NASDAQ:TVTX) Filspari (sparsentan), the only Dual Endothelin Angiotensin Receptor Antagonist for IgA nephropathy (IgAN).