FDA Related News

Human Drugs

Lilly Reports Favorable Data in Mounjaro CV Trial

Eli Lilly reports favorable data from the SURPASS-CVOT trial that showed its diabetes drug Mounjaro (tirzepatide) matched the cardiovascular benefits ...

Medical Devices

FDA Approves SetPoint Medical Arthritis Device

FDA approves SetPoint Medicals SetPoint System, a novel neurostimulation device to treat some rheumatoid arthritis patients.

Biologics

Makary Blames NIH for Covid Virus

FDA commissioner Martin Makary pushes the idea that the National Institutes of Health funded the Wuhan, China, lab from which the Covid-19 virus escap...

Human Drugs

15 Observations in Jubilant HollisterStier FDA-483

FDA has released the form FDA-483 issued with 15 observations from an inspection at the Jubilant HollisterStier drug manufacturing facility in Kirland...

Medical Devices

Cardiosense Wearable Cleared as Heart Function Monitor

FDA clears a Cardiosense 510(k) for its CardioTag device, a wearable device capable of simultaneously capturing electrocardiogram, photoplethysmogram,...

Human Drugs

FDA Makes ISTAND Pilot Permanent

FDA says the Innovative Science and Technology Approaches for New Drugs pilot is transitioning into a permanent drug development tool qualification pr...

Trump Overruled Makary, RFK, to Fire Prasad: Sources

Politico reports that despite strong support from FDA commissioner Martin Makary and HHS secretary Robert F. Kennedy, Jr., President Trump insisted th...

Human Drugs

Senate Amendment Seeks to Block Illicit Drug Imports

U.S. Senators Ted Budd (R-NC) and Martin Heinrich (D-NM) introduce a bipartisan amendment to FDAs fiscal year 2026 spending bill to strengthen the age...

Human Drugs

FDA Orders New Mandatory Opioid Labeling

FDA orders new mandatory safety labeling changes for all opioid analgesics, a move aimed at curbing long-term misuse of the products.

Medical Devices

MDUFA Small Business Qualification Guide

FDA publishes a guidance explaining the process it uses to determine and qualify a MDUFA small business.