The FDA has deemed two recalls as Class I — Medline Industries for issues with its Sub-G Endotracheal Tube and Abbott for yet another issue with its HeartMate 3 Left Ventricular Assist System.

Democrats on the committee say the funding level will cause the FDA to have to cut its core programs to fund pay raises.

The letter also advises the company to “comprehensively review your website, product labels, and other labeling.

According to the FDA, the selected START participants will be able to obtain frequent advice and regular ad-hoc communication with agency staff.

A Chinese drugmaker was storing sterile injectable drugs bound for the US market on corroded metal racks which themselves stood in pools of water dripping from black mold-covered condensation pipes, ...

Lingo will track glucose and provide personalized insights and customized coaching to help people create healthy habits.

DexCom’s G7 prescription continuous glucose monitoring (CGM) system now connects directly to Apple Watch for users in the US, making it the first to offer real-time glucose readings so that users can ...

The judge explained that the court was ruling on the parties’ competing motions to exclude expert testimony under Rule 702 of the Delaware Rules of Evidence.

Bkemv, like Soliris, has a boxed warning that states that eculizumab products increase the risk of serious and life-threatening meningococcal infections.

The FDA is not required to follow the recommendations of the committee, and had expressed its own doubts about the drug in its briefing documents.

The company sent a field safety notice update in May 2024, notifying of a potential issue that could affect 100,000 units.

The FDA has selected seven rare disease therapies to participate in its Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program to accelerate the development of novel ...