The Latest Breaking News from FDA

2026’s abortion battles will be fought more in courthouses and FDA offices than at the voting booth

In 2026, the biggest battles over abortion will not be at the polls.

The Conversation · Dec 10, 2025

US health officials re-examine RSV shots despite documented safety and efficacy

The FDA is reviewing RSV vaccines, which have drastically lowered infant hospitalizations, a spokesperson confirmed

The Guardian - US · Dec 10, 2025

FDA opens safety review of injectable RSV drugs approved for babies and toddlers

Federal health officials are reviewing the safety of two injectable drugs used to protect babies and toddlers from the RSV virus

The Independent UK · Dec 9, 2025

Stem Cell Therapy Uses: What Regenerative Medicine Can Treat—and the Stem Cell Risks to Know

Stem cell therapy uses are expanding in regenerative medicine, but risks and limits remain. Learn which conditions stem cells can treat safely and which remain experimental.

Medical Daily · Dec 8, 2025

Why Requirements Management Is Critical in Regulated Device Development

In the development of regulated medical devices, adherence to stringent regulatory requirements is not optional but a foundational necessity. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others around the world enforce strict guidelines to ensure the safety, efficacy, and reliability…

inkl · Dec 8, 2025

Families of people killed in UPS cargo plane crash sue carrier for wrongful death

The crash in Kentucky of an MD-11 cargo plane killed 14 people and injured 23 others on November 4

The Independent UK · Dec 5, 2025

Praxis' Epilepsy Drug Too Good To Continue, FDA Meeting Up Next

Praxis Precision Medicines Inc. (NASDAQ:PRAX) stock rose Friday after the company shared results from the registrational cohort of the EMBOLD study evaluating relutrigine for the treatment of patients with SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs).

Benzinga · Dec 5, 2025

Denali Flags Minimal Delay After FDA Halts Rare Disease Trial Start

The U.S. Food and Drug Administration (FDA) placed a clinical hold on Denali Therapeutics Inc.’s (NASDAQ:DNLI) investigational new drug (IND) application for the Phase 1 study of DNL952 under development for Pompe disease.

Benzinga · Dec 5, 2025

FDA Warns Against Abbott Glucose Monitor Sensors After Reports Of Over 700 Injuries, 7 Deaths

The U.S. Food and Drug Administration (FDA) in December issued a safety alert urging people with diabetes to stop using select glucose sensors made by Abbott Laboratories’ (NYSE:ABT) Diabetes Care, after the company linked the devices to seven deaths and hundreds of serious injuries.

Benzinga · Dec 5, 2025

Faulty glucose monitors linked to 7 deaths and more than 700 injuries worldwide. Here’s what we know

The sensors provide real-time measurements of sugar levels in the blood, sending that data wirelessly to a device or phone.

Euronews · Dec 5, 2025