OptumHealth Care Solutions has recalled its Nimbus II Plus infusion pumps — a recall now deemed Class I by the FDA — because of the potential for the device to fail from a variety of issues. Battery ...

The first entities to sue the agency over the final rule, the American Clinical Laboratory Association (ACLA) and PCR lab HealthTrackRx, filed their lawsuit in the US District Court for the Eastern ...

How can regulators judge the efficacy and safety of a product that makes patients feel so good, so quickly, that trial blinding is impossible, and the drug’s positive effects may carry abuse potential ...

The FDA needs to regain the authority to regulate drugs used in executions, according to nine Democratic senators who Tuesday wrote separate letters to FDA Commissioner Robert Califf and Drug ...

The Twin Tube made by Vyaire Medical is being recalled due to the potential for the nozzle to separate during patient use.

Guardant intends to market the blood test as a non-invasive alternative for patients who can’t access screening colonoscopy.

In a phase 3 trial, those taking Awiqli were 80 percent more likely to experience hypoglycemia than those taking insulin degludec.

Several senators on both sides of the aisle brought up the many bipartisan bills that have passed the House and Senate committees in recent years.

Novo Nordisk has sued nine more companies for selling products billed as containing semaglutide, a primary ingredient in the Danish pharma’s popular weight loss drug Wegovy. The companies — that ...

Sanofi and development partner Regeneron are riding a regulatory roller coaster, with the EU giving Dupixent (duplilumab) a nod for chronic obstructive pulmonary disease (COPD) even as the FDA hedges, ...

A February data breach at drug distributor Cencora has exposed the personal medical information of tens of thousands of patients, according to filings with numerous state attorneys general (AG) and ...