The agency updates and modifies the alerts as needed. Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. Use the chart below to view import alerts.

Pfizer Inc. has won regulatory approval for its hympavzi drug as a treatment for hemophilia A or B without inhibitors — making it the first antitissue-factor pathway inhibitor to be allowed for ...

2024 Healthcare & Pharmaceuticalscategory US FDA approves Johnson & Johnson's device for heart condition November 7, 2024 Healthcare & Pharmaceuticalscategory Americans hungry for weight-loss ...

Sulopenem, which will now go by the commercial moniker Orlynvah, was approved by the FDA Friday to treat uncomplicated urinary tract infections (uUTIs) caused by E. coli, Klebsiella pneumoniae or ...

The US government has approved the construction of a massive new lithium mine on public land in Nevada as part of a strategy to break China’s dominance over the supply chain of critical minerals ...

“This is the first approved indication for Orlynvah and the first FDA-approved product for Iterum,” the company stated. “We are so pleased to have achieved this historic milestone and would ...

DUBLIN and CHICAGO, Oct. 25, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), today announced that the U.S. Food and Drug Administration (FDA) has approved Iterum’s new ...

Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA approved oral sulopenem etzadroxil and probenecid (Orlynvah) to treat uncomplicated urinary tract infections ...

“The FDA continues to take actions that support the development and availability of at-home tests for a variety of medical conditions.” With the approval of this new test thrusting dual COVID ...

Approval is based on phase 3 SURE 1 and REASSURE trials, highlighting its potential as a community treatment alternative. The FDA's advisory committee emphasized the need for a narrow indication and ...

Medtronic’s single-shot Pulseselect system became the first FDA-approved PFA device in December 2023, but it lacks mapping capabilities or the option to deliver RF energy from the catheter. Affera ...

Here’s everything you need to know. The FDA says there is the “presence of nitrosamine drug substance related impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.” ...