Articles about Fda

• Democrats laying groundwork for major U.S. health care reforms amid political shifts in Washington. • NIH's Bhattacharya commits to full budget spending; top FDA official announces exit. • Moves signal potential policy battles over research funding and regulatory changes.

• Johnson & Johnson has received FDA approval for a new psoriasis treatment pill, expanding therapeutic options for patients with the chronic skin condition. • The United States smoking rate has quietly reached a historical low, reflecting decades of public health efforts and tobacco control policies. • These developments represent significant milestones in pharmaceutical innovation and public health outcomes across different therapeutic areas.

• The FDA linked Raw Farm's raw cheddar cheese to seven E. coli O157:H7 cases across multiple states, a strain causing severe kidney issues, hospitalization, or death. • Producer declined recall of two products despite Sunday's FDA alert on March 16. • Outbreak underscores risks of raw milk products, prompting public warnings to avoid consumption.

• The FDA on March 13 expanded approval of GSK's Arexvy RSV vaccine to adults aged 18-49 at increased risk of lower respiratory tract disease. • Phase 3b trial data showed non-inferior immune response in younger adults compared to those 60+, targeting 21 million U.S. adults under 50 with conditions like diabetes or obesity. • RSV causes 17,000 hospitalizations, 277,000 emergency visits, and 2 million outpatient visits yearly in this group, highlighting need for broader protection amid rising cases.

• Telix Pharmaceuticals resubmitted its New Drug Application to the U.S. FDA on March 16, 2026, for TLX101-Px (Pixclara®), a PET imaging agent targeting gliomas in adults and pediatrics. • The agent received Orphan Drug and Fast Track designations from the FDA due to its potential to address unmet needs in post-treatment glioma management, with 18F-FET PET already in international guidelines but no U.S.-approved equivalent. • Glioblastoma multiforme (GBM), the most common aggressive primary brain cancer, affects about 22,000 new U.S. cases yearly, with recurrence nearly universal and median survival of 12-15 months post-diagnosis.

An FDA advisory committee has recommended the development of next year's flu vaccine, as new data from the CDC indicates the current 2025-2026 flu vaccine provides moderate protection against hospitalization for vaccinated individuals despite concerns about late-emerging H3N2 strains. The committee reviewed winter flu shot effectiveness reports published in the CDC's online MMWR journal, which showed moderate protective efficacy against severe outcomes requiring hospitalization. The timing of vaccine selection remains critical as late-emerging H3N2 variants can significantly undermine vaccine effectiveness, a concern flagged by the committee during this year's review. Current guidance continues to emphasize vaccination for those at high risk of severe illness, particularly elderly and immunocompromised populations.