The Latest Breaking News from FDA

Postmenopausal Women Who Started Testosterone Had Eightfold Higher Rate of Cardiovascular Events, Though Absolute Risk Stayed Low

A health records study linked testosterone therapy in postmenopausal women to more heart and stroke events, though absolute rates were low and the cause is unproven.

Medical Daily · Oct 15

Federal Inspectors Plan Routine Listeria Swabs Inside Deli Meat Plants Starting January 2027 After Deadly Boar's Head Outbreak

USDA inspectors plan routine Listeria surface swabs at ready-to-eat meat plants from January to March 2027. See the district schedule and who is most at risk.

Medical Daily · Oct 15

Prader-Willi Drug Vykat XR: FDA Case Reports Describe 7 Deaths and Nearly 100 Hospitalizations, but Cause Is Unproven

FDA case reports describe seven deaths and nearly 100 hospitalizations in people prescribed Vykat XR for Prader-Willi syndrome. Here is what families should know.

Medical Daily · Oct 15

Opioid Use Disorder Diagnoses Rose 32.7% Among Privately Insured Americans as Tennessee and West Virginia Top Rates

Opioid use disorder diagnoses rose 32.7% among commercially insured Americans from 2022 to 2025, with Tennessee and West Virginia posting the highest rates.

Medical Daily · Oct 15

FDA Expands Anktiva Approval to Papillary-Only Bladder Cancer That Resists BCG, Giving Patients a Nonsurgical Option

The FDA expanded Anktiva plus BCG to papillary-only bladder cancer that no longer responds to BCG. Here is who qualifies, what the data show, and what remains uncertain.

Medical Daily · Oct 15

Par Health Recalls 22 Lots of Hospital Blood Thinner Argatroban After Particles, Possibly Stainless Steel, Found in Vials

Par Health is recalling 22 lots of Argatroban Injection after particles, possibly including stainless steel, were detected. See lot numbers, NDCs, and steps for hospitals.

Medical Daily · Oct 15

More Than 1 in 10 FDA Advisory Meetings Had a Representative From a Group the Drugmaker Funded

More than 1 in 10 FDA advisory meetings included a patient or consumer rep from a group funded by the drugmaker under review, a USC study found.

Medical Daily · Oct 15

Bristol Myers Pulmonary Fibrosis Drug Admilparant Met Main Goal at 60 mg, but Higher Dose Missed

BMS said Admilparant met its phase 3 goal in pulmonary fibrosis at 60 mg, but 120 mg missed. Data are topline. What patients and families should know.

Medical Daily · Oct 15

Only 42% of High-Risk Flu Patients Started Tamiflu Over Two Seasons, and Fewer Than Half Finished the Course

A CDC-led study found only 42% of high-risk flu patients started Tamiflu, and fewer than half finished. What families should know as flu season begins.

Medical Daily · Oct 15

As FDA Weighs Wider Peptide Access, Adverse Event Reports and Two Las Vegas Intubations Sharpen Safety Questions

The FDA has not ruled on six unapproved peptides as new reports detail hospitalizations and a Las Vegas case in which two women were intubated.

Medical Daily · Oct 15