Two devicemakers in Mississauga, Ontario, recently received FDA Warning Letters, with Techlem Medical cited for quality issues and Trexo Robotics Holdings for marketing unapproved products. Techlem ...

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 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.

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 ...

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 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 ...

In responding to an FTC/HHS request for information (RFI) on how drug wholesalers and group purchasing organizations (GPOs) influence generic drug shortages, the trade group for generic and biosimilar ...

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 ...

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The FDA has finalized a rule allowing it to destroy illegal medical devices valued under $2,500 that have been refused admission into the US as a deterrence against sellers re-shipping items ...