The Latest Breaking News from FDA

More potentially radioactive shrimp recalled from brands sold at Walmart and Kroger

Cesium is a soft and flexible white metal that can cause DNA damage and increase cancer risks if consumed

The Independent UK · Aug 29, 2025

Ford Owners, Check Your Brakes: Carmaker Recalls 500,000 Vehicles Due to Brake Fluid Leak

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.

International Business Times UK · Aug 29, 2025

FDA Tightens Safety Guidelines For Biogen Leqembi Alzheimer's Therapy

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.

Benzinga · Aug 29, 2025

Departures roil the CDC leadership. What's next for the agency?

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

The Independent UK · Aug 28, 2025

Prothena Reports Non-Competitive Brain Swelling Rates In Early Alzheimer's Study

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).

Benzinga · Aug 28, 2025

Telix Gets Second FDA Rejection For Kidney Cancer Drug

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).

Benzinga · Aug 28, 2025

People in the US: share your views on the FDA’s new restrictions on Covid jabs for under-65s

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

The Guardian - US · Aug 28, 2025

FDA Eases Monitoring Burden For Kidney Disease Patients On Travere Therapeutics' Filspari

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).

Benzinga · Aug 28, 2025

RFK Jr faces calls to quit as CDC chief fired and senior staff resign: ‘an embarrassment’

Susan Monarez’s ousting and four top resignations follow vaccine confusion, leaving US health agencies in turmoil

The Guardian - US · Aug 28, 2025

FDA Rejects Outlook Therapeutics Eye Drug For Second Time

Outlook Therapeutics, Inc. (NASDAQ:OTLK) stock plunged on Thursday after the U.S. Food and Drug Administration (FDA) update.

Benzinga · Aug 28, 2025