The Latest Breaking News from FDA

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

Biogen and Eisai won Food and Drug Administration approval of an at-home shot version of their Alzheimer's treatment Leqembi.

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).

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